Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
PipCast®
PTE
Trade Marks
Webinars

Home / News / Other Updates

EXPLORE OUR

Other Updates

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.

2024

March 1, 2024

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

March 1, 2024

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

February 29, 2024

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effectsThe regulator warned that side effects can include conjunctivitis and ulcerative keratitis

February 29, 2024

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

February 29, 2024

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

February 28, 2024

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

February 28, 2024

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

February 27, 2024

On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

February 27, 2024

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission. 

February 27, 2024

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC. 

February 26, 2024

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumaboreculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.   

CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.  

February 26, 2024

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung cancer (NSCLC). The indications include treatment of squamous, non-squamous and locally advanced / metastatic NSCLC. BeiGene’s Phase 3 clinical trials, enrolling 1,500 patients, showed tislelizumab to be an effective therapy for patients with treatment-naive and treatment-resistant NSCLC. 

On 19 September 2023, BeiGene announced it regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following termination of the previous arrangement between the parties. 

February 26, 2024

On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn’s & Colitis 360.  The study involved 108 patients switched from IV to a subcutaneous vedolizumab.  The results of the study suggested that switching from an intravenous to a subcutaneous treatment of vedolizumab is convenient and safe. 

February 26, 2024

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

February 26, 2024

On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share.  Alvotech’s U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved Alvotech’s SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira®.  

February 23, 2024

On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden.  The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes.  On 25 February 2024, CHMP provided a positive recommendation for SB17.   

The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreemententered in September 2023 

February 23, 2024

Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®.  SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis.  AVT02 is already approved in CA, AU, EG, EC and Saudi 

February 23, 2024

On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this yearThis news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients. 

February 23, 2024

On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024.  Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease. 

February 22, 2024

On February 2024, Artiva Biotherapeutics announced that the FDA granted fast-track designation to its Lupus Nephritis treatment AlloNK®(AB-10) in combination with rituximab or obinutuzumab.  This was supported by the results of a phase I/II multicentre clinical trial in non-Hodgkin lymphoma which demonstrated that this combination can drive deep B-cell depletion in patients with late-line B-cell cancers. 

February 22, 2024

AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell’s portfolio notably includes GC012F a clinical stage chimeric antigen receptor T-cell therapy, which is potential new treatment for multiple myeloma, autoimmune diseases and haematologic malignancies. The total transaction is valued at $1.2B USD Previously on 12 December 2020, AstraZeneca announced its acquisition of Alexion.  

February 22, 2024

On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar).  Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults.  Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.  

Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK. 

February 21, 2024

Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®.  Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform. 

Udenyca OnBody® received FDA approval in December 2023. 

February 21, 2024

On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab).  The results came from a double blinded, randomised, single dose study which assessed PB016’s PK/PD and immunogenicity in 120 subjects, and demonstrated that PB016 has comparable PK/PD and immunogenicity to Entyvio®. 

February 21, 2024

Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab).  The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy.  This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27. 

Each of Formycon, Xbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024.

February 21, 2024

On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma.  The target action date is set for 22 August 2024.  Priority review was granted following data from a combined Ph 1 | 2 clinical trial (LINKER-MM1). 

Earlier in February 2024, the European Medicines Agency accepted for review the marketing authorisation application of linovoseltamab for the same indication.  

February 20, 2024

On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer FDA has assigned 21 June 2024 as the Prescription Drug User Fee Act (PDUFA) goal date. 

February 20, 2024

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients This approval increases dosing flexibility in patients on a weight-based dosing regimen TECVAYLI® was originally approved by the FDA in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. 

February 20, 2024

On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications.  Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.   

In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.  

In March 2023, Mabwell (Shanghai) Bioscience announced that it received Chinese marketing approval for its Mailishu® (denosumab) and it was reported in December 2023 that Celltrion applied to the FDA for marketing authorisation for its Prolia® biosimilar (CT-P41).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech. 

February 20, 2024

Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease.  Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.  

This follows Celltrion’s success in January 2024 in securing the Norwegian government tender for the supply of Remsima SC until 2026.  

February 19, 2024

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy FDA has decided the fourth quarter of 2024 as the Prescription Drug User Fee Act date The application was approved based on the Phase III results of study TROPION-Lung01 which showed that datopotamab deruxtecan significantly improved progression-free survival (PFS) in comparison to docetaxel (the current standard of care). 

February 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

February 19, 2024

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar) Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab)These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market. 

February 16, 2024

Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.  The announcement states that Xolair® is the first FDA-approved medicine to reduce allergic reactions in people with food allergies.  The approval was based on the Phase III OUtMATCH study in patients allergic to peanuts and at least two other food allergens.  Xolair was previously FDA approved for the treatment of asthma, chronic rhinosinusitis and chronic spontaneous urticaria.  

Parent company Roche announced submission of the BLA for the food allergy indication in December 2023.  Celltrion, Glenmark and Kashiv Biosciences are reported to have omalizumab biosimilars in development. 

February 16, 2024

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a phase 3 trial showing Dupixent® significantly reduced itch severity compared to placebo.  

Last month, FDA approved a new indication of Dupixent® (dupilumab) for the treatment of paediatric patients with eosinophilic esophagitis. 

February 15, 2024

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions.  AVT04 received regulatory approval in January 2024 in Europe, in September 2023 in Japan and in November 2023 in Canada.  The products will be marketed by Stada (as Uzpruvo®) in Europe from late July 2024, by Fuji Pharma in Japan (as Ustekinumab BS (F)) from May 2024, and by JAMP in Canada (as Jamteki®) from Q1 2024. 

Alvotech’s applications for AVT04 elsewhere around the world are pending, including in the US.   

In June 2023, Alvotech and Teva announced a US settlement with J&J relating to ustekinumab, with a market entry date of no later than 21 February 2025.   

February 14, 2024

BMS announced that the FDA has accepted a priority review for its Augtyro® (repotrectinib) for the treatment of patients 12 years of age and older with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity.   

On 15 November 2023, the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. 

February 14, 2024

On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications, and the EMA accepted its Marketing Authorization Applications, for use of nemolizumab in the treatment of patients with prurigo nodularis and atopic dermatitis. Galderma plans to make further regulatory submissions this year in additional countries.  

February 13, 2024

On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, biosimilar to Actemra® (tocilizumab).    

This follows the announcement by Celltrion at the end of January 2024, that that it submitted its US BLA for CT-P47. 

February 13, 2024

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar safety profiles.   

According to the study, QL1207 is the first aflibercept biosimilar developed in China.  

February 13, 2024

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab).  The study, conducted in 509 patients with moderate to severe plaque psoriasis, demonstrated equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles. 

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial on RT-111, an oral formulation of CT-P43.   

February 12, 2024

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579 The motion records that Celltrion (the petitioner) has not formally agreed to the dismissal and may file a response. 

Previously, Celltrion filed inter partes review (IPR) petitions IPR2022-00578 against Chugai/Genentech/Roche’s MOT (RA) patent no. US8580264 (‘264), and IPR 2022-00579 against Chugai/Roche’s device patent no. US10874677 (‘677).  The PTAB concluded that claims 1-12 of the ‘264 MOT patent and claims 1-8 of the ‘677 patent are invalid in view of the prior art.  Chugai, Genentech, and Hoffmann-La Roche appealed PTAB’s decision and are now seeking to have that appeal dismissed.  

February 12, 2024

Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE).  Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.  

February 12, 2024

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional systemic adalimumab HS therapy.  

This comes months after Novartis announced, on 31 October 2023, that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe HS in adults.  

February 12, 2024

On 12 February 2024, Merck announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or gastroesophageal junction adenocarcinoma with tumours expressing PD-L1 (Combined Positive Score [CPS] ≥ 1).  

In January 2024, Merck announced that the FDA approved KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy for Stage III-IVA cervical cancer. 

February 12, 2024

On 12 February 2024, Biogen announced that the European Commission approved its SKYCLARYS® (omaveloxolone) on 9 February 2024 SKYCLARYS® was approved for treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and olderThe announcement states that “SKYCLARYS® is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease”. 

February 9, 2024

On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive partnership agreement with Sandoz AG. The agreement provides Sandoz AG the right to promote, sell and distribute Biocon’s OGIVRI® (trastuzumab biosimilar) and ABEVMY® (bevacizumab biosimilar) in Australia.  

This comes months after Biocon announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan. 

February 8, 2024

A study sponsored by Mabwell (Shanghai) Bioscience Co Ltd and published in JAMA Oncology reports that the results of Chinese randomized, 53-week, phase III trials of Mabwell’s MW032 with Amgen’s Xgeva® in patients with solid tumor-related bone metastases, confirm biosimilarity in efficacy, safety and population pharmacokinetics.   

In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

February 8, 2024

A Sanofi and Regeneron study published on 11 December 2023 found that dupilumab (compared to placebo) significantly improved lung function in children with uncontrolled asthma. The study was randomised with subjects aged between 6-12 years, and the results showed that by week 12, a higher proportion of patients achieved a clinically meaningful response.

On 25 January 2024, Regeneron and Sanofi announced that the FDA approved Dupixent® (dupilumab) to treat paediatric patients, aged 1 to 11 years and weighing at least 15 kg, with eosinophilic esophagitis (EoE).

February 7, 2024

On 7 February 2024, global contract development and manufacturing company Samsung Biologics announced that it has partnered with LegoChem Biosciences for antibody-drug conjugate (ADC) development and manufacturing.  Under the agreement, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem Bioscience’s ADC program designed to treat solid tumours.  LegoChem is aiming to submit an Investigational New Drug (IND) application to the FDA in the first half of 2025.   

Samsung Biologics also reports that it is on track to complete a dedicated ADC facility in South Korea in 2024.  Two weeks ago, Samsung Biologics revealed in its Q4 2024 Earnings its record high operating profit of over ₩1T for 2023. 

February 7, 2024

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.  

Celltrion aims to expand further into the Nordic area with plans to enter into Denmark with Remsima SC® sometime in 2024.  

February 7, 2024

On 7 February 2024, Bristol Myers Squibb (BMS) announced the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).  The FDA has assigned a PDUFA goal date of 8 October 2024.   

On 5 December 2023, BMS announced that the FDA has accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma.   

February 5, 2024

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial regarding RT-111, a RaniPill® capsule containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The study shows that RT-111 was well-tolerated and delivered ustekinumab with high bioavailability. 

In June 2023, Rani Therapeutics announced that it expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), following their earlier collaboration on ustekinumab (CT-P43). 

February 5, 2024

On 5 February 2024, Novartis announced that it has agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B.   Upon completion of the acquisition, notably, Novartis would add to its portfolio the ‘next generation medicines’ of pelabresib which downregulates blood cancer and tulmimetostat used to treat endometrial cancer.

February 5, 2024

On 5 February 2024, Glaxo Smith Kline (GSK) announced results from an interim analysis of its DREAMM-7 phase III trial.  The trial compared two treatment combinations, namely: 

  • Blenrep® Combination: Blenrep® (belantamab mafodotin) +  BorDex® (bortezomib plus dexamethasone); and 
  • Daratumumab combination: daratumumab + BorDex® (bortezomib plus dexamethasone) 

The Blenrep® Combination showed: a) 59% further reduction in risk of disease progression or death, b) 23.2 more months of median progression-free survival, and c) 43% reduction in risk of death.   

February 5, 2024

On 5 February 2024, Ultimovacs announced that the FDA has granted a fast-track designation to its therapeutic cancer vaccine UV1 in combination with nivolumab and ipilimumabThis was supported by the results of a phase II clinical trial for the treatment of patients with unresectable malignant pleural mesothelioma. 

February 5, 2024

On 5 February 2024, Novo Nordisk’s parent company Novo Holdings announced that it will acquire global contract development and manufacture company Catalent for USD $16.5B.  

Novo Holdings will secure 50 global sites in the acquisition and intends to sell three fill-finish sites and related assets (located in Italy, USA and Belgium) to Novo Nordisk.  The acquisition is expected to close towards the end of calendar year 2024.  

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented an increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

February 5, 2024

Novo Nordisk settled two lawsuits over counterfeit versions of Ozempic® (semaglutide biosimilar) and Wegovy® (semaglutide).  The two companies involved, Cosmetic Laser Professionals Med Spa and Nuvida RxWeight Loss are permanently banned from claiming that their products are approved by the FDA and from using any Novo Nordisk logos or trademarks. 

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented an increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

February 4, 2024

A study published in Medicina, on 4 February 2024, concluded that Rituximab represents an efficacious and well-tolerated therapeutic option for the management of Autoimmune Bullous Diseases (AIBD) and warrants consideration in cases of refractory AIBD. 

February 2, 2024

Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM), was accepted for review by the European Medicines Agency (EMA).  The MAA is supported by data from a Phase I/II trial (LINKER-MM1) investigating linvoseltamab in R/R MM.  Regeneron also submitted a Biologics License Application (BLA) to the FDA in December 2023.

February 1, 2024

Shanghai Henlius Biotech announced its phase 1 clinical study for its denosumab biosimilar of HLX14, which met the primary endpoint.

Shanghai Henlius Biotech announced commencement of the study in November 2020.  Organon announceda deal in June 2022 for exclusive global commercialisation rights to Shanghai Henlius Biotech’s denosumab and pertuzumab.

February 1, 2024

Merck published its Q4 and full year financial results, reporting Q4 2023 worldwide sales were US$14.6B, a 6% increase from Q4 2022.  It also reported a 19% increase in sales of Keytruda® (pembrolizumab) worth US$25B across 2023.  Merck explained the Keytruda® sales increase was due to increased global uptake in earlier-stage and metastatic indications.

Merck highlighted that Keytruda® received multiple FDA approvals, including Keytruda® plus Padcev®.  It also reiterated that the FDA granted Priority Review of Merck and Daiichi Sankyo’s Biologics License Application for patritumab deruxtecan to treat certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

February 1, 2024

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical will co-market SB15, Samsung’s biosimilar of Regeneron’s Eylea® (aflibercept) in Korea.  The agreement intends to utilise Samsung’s R&D capabilities with Samil Pharmaceuticals’ sales and marketing expertise.

On 21 June 2022, Samsung Bioepis and Samil also entered a commercialisation agreement for Amelivu®, a biosimilar to Genentech’s Lucentis® (ranibizumab).

January 31, 2024

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®.  The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.   

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®.  Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it.  Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US. 

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions.  At that time, the detailed reasons remained under seal.  Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one. 

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). 

January 31, 2024

Novo Nordisk announced in its 2023 Annual Report that it has increased sales by 31% to DKK 232.3B in 2023, and increased its operating profit by 37% in Danish Kroner.  Key developments outlined in the Report include:

  • a 51% net profit increase and 49% increase in share price;
  • a total of DKK75B investment in expanding global production sites in 2023;
  • 40.5M people accessed Novo Nordisk’s diabetes care products;
  • a summary of the SELECT trial which showed cardiovascular benefits of semaglutide, including a 20% reduction in major adverse cardiovascular events compared to a placebo; and
  • an update on Novo Nordisk’s once-weekly insulin product (Insulin icodec).

January 31, 2024

Outlook Therapeutics announced that it has dosed the first subject in its clinical trial (NORSE EIGHT) which aims to evaluate the effect of ophthalmic formulation of bevacizumab (ONS-5010), in patients suffering from neovascular age-related macular degeneration (wet AMD).

On 23 January 2024, Outlook Therapeutics announced that it received approval from FDA under a Special Protocol Assessment for its ONS-5010 clinical trial protocol.

January 31, 2024

Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS).  Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen’s Tysabri® (natalizumab) to be launched in Europe.

The EC approved Sandoz’s Tyruko® in September 2023, and it was approved by the FDA in August 2023.

January 31, 2024

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”.  Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the current clinical study.

On 22 April 2022, Biogen withdrew its EU MAA for aducanumab following feedback from the CHMP.

January 31, 2024

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with Merck’s Keytruda® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.  On 26 January 2024, the EMA approved a Type II variation for the same indication.

January 31, 2024

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiveness over a long period of time, compared to originator medicines etanercept and adalimumab respectivelyThe study recruited a total of 1598 patients with rheumatoid arthritis and monitored them for over 48 months during treatment

January 30, 2024

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment, and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma (NDMM) and are eligible for autologous stem cell transplant.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).

January 29, 2024

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

On 18 October 2023, the European Commission approved Enhertu® to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

January 29, 2024

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult male subjects 28to 55 years old.  The results of the study have not yet been published.

On 7 September 2022, Lupin and partner DKSH announced an exclusive licensing and supply agreement to market Alvotech’s AVT03 and four other Alvotech biosimilar products (golimumab, aflibercept and two undisclosed biosimilars for immunology and oncology) in the Philippines.

January 29, 2024

Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

January 28, 2024

Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA.  Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA approval for Tofidence®, its biosimilar Actemra® on 30 September 2023.  On 1 August 2022 the FDA accepted Fresenius Kabi’s BLA for its tocilizumab biosimilar.

On 14 December 2023, Celltrion revealed that its phase III clinical trial of CT-P47 demonstrated equivalence with Actemra® in patients with rheumatoid arthritis.

January 26, 2024

AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore.  The investment will add 24,000L of biologics drug-substance capacity to AbbVie’s manufacturing network.  The expansion intends to support current products and emerging immunology and oncology compounds.  Construction will begin later in 2024, with operations expected to commence in 2026.

January 25, 2024

A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory bowel disease who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.

January 25, 2024

Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE).  Dupixent® is the first and only medicine approved in the US to treat these patients.  It was approved to treat EoE patients 12 years and older in May 2022.

On 6 May 2023, a Regeneron-sponsored study concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of EoE.

January 25, 2024

Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion Korean won) annual revenue in 2023 for the first time in the company’s history.  This was due to the 8% growth in revenue from new product launches and sales expansion.

Parent company Samsung Biologics’ operating profit of over ₩1T was also a record high.  On 25 October 2023, Samsung Biologics reported its highest ever quarterly consolidated revenue of over ₩1T.

January 24, 2024

A study published in JAMA Dermatol shows that rituximab had positive shortterm efficacy and safety when compared to a standard corticosteroid regimen for patients with pemphigus.  

January 24, 2024

The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab).  It is indicated to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Onbevzi® is marketed by Samsung Bioepis as Aybintio® in Europe, which was approved by the European Commission on 20 August 2020.

January 24, 2024

Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review.

On 19 January 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Bayer’s Eylea® 8mg to treat nAMD and visual impairment due to diabetic macular oedema (DMO).

January 23, 2024

WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).  Under the agreement, WuXi will be Celltrion’s primary service provider for its projects, including from process development to GMP manufacturing.

On 11 January 2024, WuXi XDC’s parent company WuXi Biologics signed a $20M research service agreement with BioNTech to develop two monoclonal antibody therapeutics.

January 23, 2024

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential resubmission of its biologics license application (BLA) by the end of 2024.  Outlook has also entered into securities purchase agreements for up to $172M to fund the advancement of ONS-5010.

Outlook submitted its SPA request to the FDA regarding the design of the study on 19 December 2023.

January 22, 2024

A Bristol Myers Squibb (BMS) study published in the Journal of Clinical Oncology concluded that Opdivo® (nivolumab) plus chemotherapy did not significantly improve progression-free survival versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated metastatic non-small-cell lung cancer previously treated with EGFR tyrosine kinase inhibitors. The study was sponsored by BMS in collaboration with ONO Pharmaceutical Company. 

January 22, 2024

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursement talent and access to proprietary commercial software.  Closing is anticipated in the first half of 2024, subject to standard conditions and approvals.

Coherus announced its sales of Cimerli® surpassed 100,000 doses in its first year in the US following launch in October 2022.

January 22, 2024

PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety.  Episcli® is approved to treat nocturnal hemoglobinuria.

On 3 January 2024 Alexion sued Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six of its eculizumab patents.

January 22, 2024

The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s Stelara® (ustekinumab), in Australia.  The vial and pre-filled syringe for subcutaneous injection have been approved to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease (CD) and ulcerative colitis (UC).  The vial for IV infusion is indicated for CD and UC.

The FDA approved Wezlana® as the first biosimilar to Stelara® on 31 October 2023.

January 19, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bayer’s Eylea®8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).

Eylea® 8mg was approved in Japan on 18 January 2023, and in Europe on 8 January 2024, for nAMD and DMO.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 19, 2024

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “readily addressable”.  The company believes it is in a position to receive FDA approval for AVT02 (adalimumab, biosimilar to AbbVie’s Humira®) and AVT04 (ustekinumab, biosimilar to Janssen’s Stelara®) by their respective goal dates of 24 February 2024 and 16 April 2024.

The European Commission granted marketing authorisation for AVT04 under the brand name Uzpruvo® – the first EU-approved biosimilar to Stelara® – on 10 January 2024.

January 19, 2024

The US Food and Drug Administration (FDA) announced that it is adding a Boxed Warning to the prescribing information for Amgen’s Prolia® (denosumab) about the significant risk of developing severe hypocalcemia (very low blood calcium levels) in patients with advanced chronic kidney disease, particularly patients on dialysis.

The FDA announced its investigation into this risk in November 2022.  Prolia® is approved in the US for the treatment of osteoporosis in men and women, and to increase bone mass in patients receiving certain therapies for prostate cancer and breast cancer.

January 18, 2024
Korea Biomedical Review reported that CanariaBio received a recommendation from Korea’s Data and Safety Monitoring Board (DSMB) that it stop its global phase III clinical trials of oregovomab in ovarian cancer patients, but continue to monitor overall survival.  The recommendation was due to a failure to achieve the necessary statistical value (p-value) in the futility analysis.

January 18, 2024

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).  The approval was based on studies comparing Eylea® 8mg dosed at 12 or 16 week intervals compared to Eylea® 2mg dosed at 8 week intervals, following initial monthly doses.  Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer is the licensee of exclusive marketing rights outside the US.

On 8 January 2024, Bayer received MA from the European Commission for Eylea® 8mg for the same indications as Japan.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 17, 2024

On 17 January 2024 Samsung Bioepis released its fourth US Biosimilar Market Report.  The quarterly report details recent prices of US-launched biosimilars, and market share and price trends.  The report covers the US-approved biosimilars on 14 INNs, of which 45 have been approved (including three in Q4 2023) and 38 launched.  Of note in relation to adalimumab, Samsung Bioepis points out that six months afterthe July 2023 launch of seven biosimilar products, biosimilar adoption in the US is at 2%.

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that  biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023, and the third report was published on 10 October 2023.

January 17, 2024

Business Korea reported that Celltrion launched its 80mg dose of Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in the US on 17 January 2024.  It is the same high-concentration (100mg/mL) formulation as the 40mg dosage form already available in the US.  Celltrion will launch a 20mg dose for paediatric patients in Q1 2024.

Last week Celltrion won several European bids to supply Yuflyma®.

January 17, 2024

The Hindu reported that Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for marketing authorisation for its trastuzumab (biosimilar to Genentech’s Herceptin®) from India’s  Subject Experts Committee of the Central Drugs Standard Control Organization (CDSCO).

In relation to another molecule (ustekinumab), CuraTeq Biologics entered into an exclusive commercialisation agreement with BioFactura in July 2023.

January 16, 2024

A study evaluating results from a Phase 3, randomised, double blind trial sponsored by Samsung Bioepis was published on 16 January 2023 in the journal, Frontiers in Pharmacology. The results show that Samsung Bioepis’ SB8 (bevacizumab biosimilar) had a comparable efficacy to Genentech’s Avastin® (bevacizumab) for treatment of non–small cell lung cancer.

On 24 January 2024, the Therapeutic Goods Administration (TGA) approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab), to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

January 16, 2024

Roche announced that the European Commission (EC) has granted it marketing authorisation for Tecentriq® SC (atezolizumab) for subcutaneous injection.  The new authorisation applies to all indications already approved for the previous formulation of Tecentriq® (administered by IV infusion) including various lung, liver, bladder and breast cancers.

The Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq® SC (the new formulation) on 14 November 2023.

January 16, 2024

Regeneron and Sanofi announced that the FDA has updated the Dupixent® (dupilumab) label to include efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement.  The new data has also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.  The data is from the first and only trial evaluating a biologic specifically for this difficult-to-treat population.

On 27 November 2023, Sanofi and Regeneron announced they plan to file a supplemental biologics licence application with the FDA for Dupixent® to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.

January 15, 2024

Korea Biomed has reported that Samsung Bioepis will stop supplying the low concentration formulations of Adalloce®, biosimilar to AbbVie’s Humira® (adalimumab), in Korea.  Samsung Bioepis will continue to supply Adalloce® in two high-concentration formulations: Adalloce® prefilled syringe and pen (both 40mg/0.4mL).

January 15, 2024

Korea Biomed has reported that LG Chem plans to launch Xelenka®, its biosimilar to AbbVie’s Humira® (adalimumab), in Korea in the second half of 2024, despite obtaining approval from the Korean Ministry of Food and Drug Safety on 15 December 2023.  The report states that the company is “still considering sales strategies”.

January 15, 2024

Boan Biotech announced that it has completed enrolment for the international multi-centre comparative clinical phase III study of BA6101 and BA11021, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The studies are being condu­­cted simultaneously in Europe, the United States, and Japan.

Boan commenced the trials in May 2023.  BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world, and China’s NMPA has accepted Boan’s BLA for approval as an Xgeva® biosimilar.

January 15, 2024

Biospectrum India reported that Indian-based Enzene Biosciences announced its plans to establish a continuous manufacturing site in Hopewell, New Jersey.  Enzene intends the manufacturing site to be operational in June 2024.  Enzene also announced its plans to “gradually expand” operations across the EU, US, Canada, Australia, and Japan.

Enzene launched its seventh Indian biosimilar (ranibizumab) on 24 November 2023.

January 12, 2024

Korea Biomedical Review reported that Celltrion has won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) in Friuli-Venezia Giulia (FVG) and Sicily in Italy, as well as in the south eastern region of Netherlands. Celltrion will supply Yuflyma® for four and a half years in FVG, two years in Sicily, and for the next three years in the Netherlands.  Celltrion also won a bid to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) in Sicily for two years.

On 18 September 2023, Celltrion won bids to supply Yuflyma® in five other regions of Italy, amounting to 20% of the Italian adalimumab market.

January 12, 2024

Merck announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.

January 11, 2024

WuXi Biologics announced that it has signed a research service agreement with BioNTech under which Wuxi will receive a $20M upfront payment, and BioNTech is granted exclusive rights to develop therapeutic candidates from two undisclosed preclinical investigational monoclonal antibodies discovered by WuXi.  WuXi is eligible for additional payments including for R&D, regulatory and commercial milestones, and tiered royalties.

January 11, 2024

Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA).  The SAG is expected to meet before 31 March 2024.  The SAG is being convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation.

On 9 January 2024, the Chinese NMPA approved Leqembi® as a treatment for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  

January 11, 2024

Celltrion announced in a corporate filing that it applied to the FDA seeking interchangeable status for CT-P17 (Yuflyma®), biosimilar to AbbVie’s Humira® (adalimumab), on 9 January 2024.  On 2 October 2023 the FDA approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

January 10, 2024

Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents.  The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics Drug Application (aBLA) for ABP938, Amgen’s biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron is seeking a preliminary and permanent injunction against Amgen, a finding of willful infringement, damages (including enhanced damages for wilful infringement) and costs.

Regeneron filed its fourth aflibercept complaint in the US District Court for the Northern District of West Virginia against Formycon on 29 November 2023.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

January 10, 2024

Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for Uzpruvo® (AVT04), the first EU-approved biosimilar to Janssen’s Stelara® (ustekinumab).  The marketing authorisation is valid in all European Economic Area countries, including the 27 European Union Member States as well as in Iceland, Liechtenstein, and Norway.  The announcements state the approval ‘paves the way’ for market entry as soon as possible after expiry of a European Supplementary Protection Certificate (SPC) for Stelara® in July 2024.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Uzpruvo® (AVT04) on 10 November 2023.

January 10, 2024

Celltrion announced the next phase of its strategic transformation to focus on new drug development at the JP Morgan Healthcare Conference in San Francisco, California.  Celltrion discussed the company’s strategic priorities and progress, including its vision to move beyond biosimilars through the 2024 launch of Zymfentra® (the first and only FDA-approved subcutaneous infliximab product) and expansion into digital healthcare.  Celltrion will continue to develop a pipeline of biosimilars including antibody-drug conjugates, immune checkpoint inhibitors and multi-specific (bi/tri-specific) antibody drugs. Celltrion aims to have a portfolio of 11 drugs by 2025 and a total of 22 drugs by 2030.

January 9, 2024

The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to methods of treatment using Eylea® (aflibercept) are invalid.  The PTAB held in IPR2022-01225 and IPR2022-01226 that all challenged claims of the two patents were anticipated by a journal publication which disclosed aflibercept for age-related macular degeneration (AMD), and disclosed phase I and II data relating to its use in neovascular AMD.  The inter partes review (IPR) proceedings were filed by Mylan in July 2022 and instituted in January 2023.

On 23 March 2023, PTAB instituted Celltrion’s IPR challenge to ‘601 and ’681 and Samsung Bioepis’ IPR challenge to ‘601.  PTAB also granted Celltrion and Samsung Bioepis’ motions to join the Mylan IPRs. Samsung Bioepis’ IPR2023-00442 challenge to the ‘681 patent is still pending before the PTAB.

 

 

January 9, 2024

A study published in Ocular Immunology and Inflammation found that switching patients with non-infectious uveitis (NIU) from AbbVie’s Humira® to Samsung Bioepis’ Adalloce® (SB5) did not result in clinically significant efficacy or safety differences.  The study was funded by the National Research Foundation of Korea.

On 19 December 2023, a Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated SB15 was comparable to Regeneron’s Eylea® (aflibercept).

January 9, 2024

Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration (NMPA) in China for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  Eisai has begun preparation for launch in Q3 2024.

On 22 December 2023, it was reported that Eisai will apply to the US FDA to expand approval for Leqembi® for prevention of AD as soon as April 2026.  Leqembi® was approved in Japan on 25 September 2023, and received traditional approval in the US on 6 July 2023.

January 9, 2024

GSK and Aiolos Bio announced they have entered into an agreement for GSK to acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing respiratory and inflammatory conditions, for $1B upfront and up to $400M in milestone payments.  Aiolos’ AIO-001 is a monoclonal antibody (mAb) ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps.  AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals.

January 8, 2024

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).  Eylea® 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses, and in patients with stable visual outcomes intervals of up to five months may be considered.  Eylea® 8 mg is the only treatment in the EU approved for extended treatment intervals of up to five months in nAMD and DMO.

Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer has licensed the exclusive marketing rights outside the US.

On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.  The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the 8mg Eylea® for the treatment of nAMD and DMO in November 2023, however Eylea® is not approved for diabetic retinopathy in the EU.

January 5, 2024

The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®, biobetter to Remsima® (IV product), biosimilar to Janssen’s Remicade® (infliximab), in the first nine months of 2023 by 48% year on year.  Celltrion expects Remsima SC® to generate annual sales in Australia of more than AUD$17M in 2023.  Remsima SC® was approved by the TGA on 12 November 2020.

January 4, 2024

AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy medicinal products (ATMPs) in Yokohama Japan.  It expects the site to be operational in 2026.

The 20,000 m² facility will offer pre-clinical through to commercial services for mammalian-based protein biologics, messenger RNA (mRNA) and cell therapy services.

In 2021, AGC Biologics and Xbrane Biopharma entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

January 4, 2024

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021.  Accord BioPharma will be responsible for US commercialisation.

In the same announcement, Accord announced that in October 2023 it reached a settlement with Janssen that would allow Accord to launch DMB-3115 in the US no later than 15 May 2025, pending FDA approval.

January 4, 2024

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea® (aflibercept).  Regeneron has sought authorisation to serve Samsung Bioepis, Celltrion and Formycon by email to their respective US counsel.  All three defendants submit that they intend to file motions to dismiss their matters for lack of personal jurisdiction, without waiting for service, rendering the issue of service moot.

On 27 December 2023, the US District Court for the Northern District of West Virginia found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents, with two of those patents were invalid for obviousness.

January 3, 2024

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India.  Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product.  Lirafit® is indicated for improving glycaemic control in adult patients with type 2 diabetes mellitus.

January 3, 2024

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) on 7 July 2023.  Soliris® is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and other conditions.  On 7 July 2023, Samsung provided its 180-day notice of commercial marketing to Alexion.

In August 2023, Amgen appealed Alexion’s successful preliminary injunction order regarding Amgen’s off-label use of its eculizumab biosimilar Bekemv® in Germany.

January 3, 2024

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea® in patients with neovascular (wet) age-related macular degeneration.  The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT06 and Eylea®.

In May 2023, Alvotech and Polifarma announced an exclusive commercialisation agreement for AVT06 in Turkey.

January 2, 2024

Coherus Biosciences announced that it has launched Loqtorzi® (toripalimab-tpzi) in the US.  It was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine to treat adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

January 2, 2024

AstraZeneca and Sanofi announced that Beyfortus® (nirsevimab) has been approved by the National Medical Products Administration (NMPA) in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.  The companies anticipate Beyfortus® will be available during the upcoming 2024-2025 RSV season.  Beyfortus® is the first approved preventive option to protect against RSV in a broad infant population.

The FDA approved Beyfortus® for the same indication and to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season on 17 July 2023.

January 2, 2024

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib.  BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pre-treated adult and paediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumours.

On 15 November 2023 the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

January 1, 2024

Cipla’s Adalicip®, developed by Alvotech (AVT02), biosimilar to AbbVie’s Humira® (adalimumab) has been listed on the PBS (General Pharmaceutical Benefits) in the 40mg/0.4mL dosage in syringes and pen devices.  It is reimbursed to treat various conditions, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

Cipla’s public summary document for Adalicip® was published on 27 October 2023, and it was considered at the July 2023 PBAC meeting.

January 1, 2024

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new International Recognition Procedure (IRP), allowing medicine developers to now submit applications.  The IRP replaces the EC Decision Reliance Procedure after the UK left the EU in 2016, and allows the MHRA to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.  The MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the European Economic Area.

2023

December 27, 2023

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement.  This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first of which was filed on 21 November 2023.  

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents including  US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 on April 2023, US10,888,601 on April 2023 and US10,130,681 on January 2023. 

December 27, 2023

Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents.  The Court published a short form judgment and concluded that:

  • Mylan infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the formulation patent no. 11,084,865;
  • Mylan would induce infringement of claims 6 and 25 of method of treatment patent no. 11,253,572 and claims 11 and 19 of patent no. 10,888,601;
  • the relevant claims of ‘865 were valid (Mylan’s arguments they were invalid for lack of novelty, inventive step, written description, enablement or indefiniteness failed);
  • claims 6 and 25 of ‘572 and claims 11 and 19 of ‘601 lacked inventive step.

The valid ‘865 patent expires in the US on 14 June 2027.  Detailed reasons for the findings are under seal.  Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®.  On 27 April 2023, Regeneron filed a stipulation to narrow the case to the above three patents.  Regeneron’s Complaint asserts that the FDA notified Mylan of acceptance of its aBLA on 28 December 2021.

December 27, 2023

Formycon announced that the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

On 29 November 2023, Regeneron sued Formycon in the US for infringement of 39 of its Eylea® patents.

December 27, 2023

The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada.  The application includes all Xolair® indications, including allergic asthma, chronic rhinosinusitis and chronic urticaria.

Celltrion applied for European marketing authorisation for CT-P39 in April 2023.

December 26, 2023

Coherus Biosciences announced it received FDA approval for Udenyca OnBody® the on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  Commercial availability is planned for Q1 2024.

Coherus resubmitted its Biologics License Application (BLA) supplement for Udenyca OnBody®  to the FDA in October 2023, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

December 26, 2023

Celltrion announced in a corporate filing that its phase III clinical trial demonstrated that CT-P17, biosimilar to AbbVie’s Humira® (adalimumab), is interchangeable with Humira® in patients with plaque psoriasis.  Celltrion plans to apply to the FDA for interchangeability status in the US.

December 22, 2023

Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026.  Clinical trials are in the final stages.  Leqembi® was co-developed by Eisai and Biogen.

Leqembi® was approved in Japan on 25 September 2023 and received traditional approval in the US to treat AD on 6 July 2023.

December 22, 2023

Biocon Biologics announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan.

Biocon Biologics acquired the global biosimilars portfolio of Viatris with a deal signed in November 2022.  It completed integration in Europe in November 2023, and in North America in September 2023.  The most recent announcement states that Viatris will continue to provide transition support until Sandoz assumes responsibility for the product from 15 February 2024.

December 22, 2023

Daiichi Sankyo and Merck announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date for its regulatory decision of 26 June 2024.

December 21, 2023

Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.

December 20, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent.  The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and IPR2023-01070 respectively.  The patents cover method of treatment claims in treating paroxysmal nocturnal hemoglobinuria (PNH).

On 8 December 2023, PTAB instituted three other Samsung Bioepis petitions against Alexion’s Soliris® patent: US patent nos. 9,725,504, 9,718,880 and 9,732,149.  Samsung Bioepis launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023.  Epysqli® was approved by the EMA on 30 May 2023.

December 20, 2023

The Business Standard reported that AstraZeneca Pharma India said it will launch Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer in India in January 2024.

December 20, 2023

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune disorders.  mAbxience (majority owned by Fresenius Kabi, partially owned by Insud Pharma) will develop, manufacture and supply the etanercept biosimilar.

On 20 September 2023, mAbxience reached an agreement with Abbott to commercialise several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.

December 19, 2023

A Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated that SB15, its biosimilar to Regeneron’s Eylea® (aflibercept), had comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea® up to week 56 in patients with neovascular age- related macular degeneration  (nAMD).  The study also showed that switching from Eylea® to SB15 maintained comparable clinical efficacy and safety.  The authors claim that the results support biosimilarity between SB15 and Eylea®.

Samsung Bioepis announced the phase III switching study results for SB15 on 7 October 2023.

December 19, 2023

A study published in Reumatismo found that Samsung Bioepis’ SB4, biosimilar to Amgen’s Enbrel® (etanercept), and Amgen’s ABP501, biosimilar to AbbVie’s Humira® (adalimumab) both have similar safety profiles to their respective originator products in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.  The study also found that there was a reduced biosimilar retention rate at 24 months.  It concluded that biosimilars “could be considered a valid, safe, and less expensive alternative to originators”.

December 19, 2023

Outlook Therapeutics announced that it has submitted a Special Protocol Assessment (SPA) request to the FDA regarding the required additional adequate and well-controlled study of ONS-5010.  An SPA is a process in which sponsors ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies.

On 27 November 2023, Outlook announced it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010.  It stated the FDA said Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment-naïve patients with a primary efficacy endpoint at 2 months.

The FDA is expected to provide a response to the SPA in early February 2024.

December 19, 2023

Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods.  The BLA relates to treatment of adult and paediatric patients aged one year and older with food allergy.  The FDA expects to make a decision on approval in Q1 2024.  In the US Genentech (Roche) and Novartis  co-promote Xolair®.

December 19, 2023

Merck announced that the US FDA has accepted for priority review its new Biologics License Application (BLA) for V116, its investigational 21-valent pneumococcal conjugate vaccine for invasive pneumococcal disease and pneumococcal pneumonia in adults.  The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of 17 June 2024.

December 18, 2023

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved validity period of the clinical trial drugs without obtaining approval from the MFDS, and deviated from the approved labelling requirements.  The MFDS confirmed Samsung breached the Pharmaceutical Affairs Act and invoked a suspension of the clinical trial until 2 February 2024, despite the clinical trials having already concluded.

On 7 October 2023, Samsung Bioepis announced its Phase III switching study results for SB15 which confirmed interchangeability and biosimilarity with Eylea®.

December 15, 2023

Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean Ministry of Food and Drug Safety to treat rheumatoid arthritis, psoriatic arthritis, uveitis in adults, Crohn’s disease, and juvenile idiopathic arthritis in children.  LG Chem obtained approval for its adalimumab biosimilar in Japan back in March 2021.

December 15, 2023

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

This approval comes considerably earlier than expected.  Merck announced only in November 2023 that the FDA had accepted (for priority review) its new supplemental Biologics License Application (sBLA) seeking this approval.  At that time the FDA had set a target action date of 9 May 2024.

December 15, 2023

Korea Biomedical Review reported that MSD Korea’s Tukysa® (tucatinib) was approved by Korea’s Ministry of Food and Drug Safety to treat HER2 (human epidermal growth factor receptor)-positive locally advanced or metastatic breast cancer that has recurred after at least two anti-HER2 treatments, in combination with the antibody therapy trastuzumab and the cytotoxic anticancer agent capecitabine.  Tukysa is approved in over 38 countries.

December 15, 2023

Harbour BioMed’s wholly-owned subsidiary Nona Biosciences announced that it has entered into an exclusive license agreement with Pfizer for the global clinical development and commercialisation of HBM9033, Nona’s MSLN-targeted antibody-drug conjugate (ADC).  MSLN is a tumor-associated antigen upregulated in various solid tumors.  Nona will receive up to US$53M in upfront and near-term payments, with potential for payments up to US$1.05B contingent on achievement of development and commercial milestones.

In July 2023, Pfizer reached another large value deal with Samsung Biologics worth US$897M for Samsung’s manufacture of biosimilars.

December 14, 2023

Celltrion filed an inter partes review (IPR) petition challenging Regeneron’s Eylea® aflibercept  patent no. 11,253,572, in IPR proceeding IPR2024-00260.  Celltrion also filed a motion for joinder with Samsung Bioepis’ IPR (IPR2023-00884) of the ‘572 patent which was instituted in November 2023.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

December 14, 2023

CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the first treatment for HAE in the US and Europe to target activated Factor XII.

December 14, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that its phase III clinical trial of CT-P47, biosimilar to Genentech’s Actemra®/Roactemra® (tocilizumab), demonstrated equivalence with the originator product in patients with rheumatoid arthritis.  Celltrion confirmed it intends to apply for approval for all indications that Actemra®/Roactemra® is approved for.  On 31 May 2023 Celltrion released its phase I data for CT-P47.

December 13, 2023

Amgen announced that the FDA has accepted for priority review its Biologics License Application (BLA) for tarlatamab to treat patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.  The FDA assigned a PDUFA goal date of 12 June 2024.

December 12, 2023

Eisai and Biogen announced that Leqembi® intravenous infusion (lecanemab) will be launched in Japan on 20 December 2023, after it was scheduled on the Japan National Health Insurance (NHI) Drug Price List.  Leqembi® intravenous infusion was approved in Japan on 25 September 2023 for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease.

December 12, 2023

Sandoz subsidiary Lek announced it has commenced construction of its US$400M biopharmaceutical production centre in Lendava, Slovenia.  The facility aims to be Europe’s most efficient producer of active pharmaceutical ingredients for biologics, and will have approximately 40,000 m2 surface area.  Full operation is planned for the end of 2026.

Sandoz signed an MOU to build the facility on 9 March 2023.

December 11, 2023

Celltrion USA announced that large Medical Benefits Manager Ventegra® will add Vegzelma®, Celltrion’s biosimilar to Genentech’s Avastin® (bevacizumab) on its commercial formulary as a preferred brand. Vegzelma® (bevacizumab-adcd) was approved by the FDA to treat six types of cancer in September 2022.

On 5 October 2023, Celltrion USA announced that Ventegra® will add Yuflyma®, Celltrion’s biosimilar to AbbVie’s Humira® (adalimumab) as a preferred drug to its formulary.

December 11, 2023

Lotus Pharmaceutical announced that it has entered into a partnership with Intas Pharmaceuticals for the commercialisation of Intas’s Prolia® (denosumab) biosimilar in South Korea, Taiwan and certain markets in South East Asia.  According to the announcement, Intas will be responsible for development, manufacture and supply of the biosimilar, and Lotus will be responsible for the regulatory process and obtain commercialisation rights in those territories.

December 8, 2023

The FDA approved Vertex/CRISPR Therapeutics’ Casgevy® and Bluebird Bio’s Lyfgenia®, the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.  Casgevy® is the first FDA-approved treatment that uses CRISPR/Cas9 to genetically modify a patients’ hematopoietic stem cells.  Lyfgenia® uses a lentiviral vector for genetic modification and is approved to treat patients with a history of vaso-occlusive events.

In each instance, the patient’s blood stem cells are harvested, and treated and the modified stem cells are transplanted into the patient where they engraft within the bone marrow and increase the production of foetal haemoglobin (for Casgevy®) and HbAT87Q, a gene-therapy derived haemoglobin that functions similarly to haemoglobin A (for Lyfgenia®), and in each instance the increased levels of reduce the risk of red blood cells sickling.

December 8, 2023

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in the US, and this is the second Bio-Thera biosimilar to be US approved.

The Avzivi trade name is owned by Novartis, but the product will be marketed by Sandoz in the US pursuant to the license and commercialisation agreement entered into between Bio-Thera and Sandoz in September 2021.  Avzivi® is currently under regulatory review by the EMA (MA submitted on 26 November 2020).  Avzivi® has already been approved in China and is being supplied as Pobevcy®.

December 8, 2023

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/Merck’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab, is advanced (stages 3 and 4) and is HRD positive (BRCA1 or BRCA2 mutation or genomic instability).

On 24 August 2023, AstraZeneca announced the Japanese MHLW expanded the approval for Lynparza® with abiraterone to treat BRCAm mCRPC.

December 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) petition challenging Regeneron’s Eylea® (aflibercept) patent no. 10,464,992 in IPR proceeding IPR2023-01312.  The patent claims formulations of aflibercept suitable for intravitreal injection.  Samsung Bioepis also successfully filed a Motion for Joinder requesting to join the proceeding with IPR2023-00462, in which PTAB instituted Celltrion’s IPR against the ‘992 patent.

On 18 August 2023 Samsung Bioepis filed an IPR petition against ‘992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

December 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-00933 respectively.  The patents cover method of treatment, pharmaceutical composition and API claims.

Samsung Bioepis recently launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.

December 7, 2023

Bioeq and Teva jointly announced that Health Canada granted a Notice of Compliance for Ranopto® (ranibizumab), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration, the treatment of visual impairment due to diabetic macular oedema or choroidal neovascularization, as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion.

FYB201/Ranopto® was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. Following successful approvals in the UK (marketed as Ongavia® by Teva) in May 2022, as well as the US (marketed as Cimerli® by Coherus) and the EU (as Ranivisio®) in August 2022, Ranopto® is expected to launch in Canada in Q1 2024.  MS Pharma will commercialise FYB201 in the Middle East and North Africa (MENA) region following approval by the relevant regulatory authorities.

This is the third ranibizumab biosimilar approved in Canada, after Samsung Bioepis’ Byooviz® was approved in March 2022, and Roche’s Susvimo® was approved in September 2022.

December 7, 2023

Carefirst and another Blue Cross/Blue Shield licensee have brought class action proceedings against Johnson & Johnson (J&J) and Janssen alleging that the companies unlawfully delayed the introduction of biosimilar competition for its Stelara® ustekinumab product onto the US market.  The complaint alleges that J&J would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and that J&J delayed biosimilar competition through a series of unlawful acts to unlawfully prolong patent protection for Stelara® well beyond September 2023.

December 6, 2023

Dr. Reddy’s and Coya Therapeutics today announced that they have entered into a development and license agreement for the development and commercialisation of COYA302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).  COYA302 is a co-pack kit containing a combination of low dose IL-2 and CTLA-4 Ig (abatacept).

Under the agreement Coya granted Dr. Reddy’s an exclusive license to commercialise COYA302 in the US, Canada, the EU and the UK for ALS.  The new agreement is in addition to the exclusive worldwide licensing agreement between the companies to use the Dr Reddy’s abatacept biosimilar (to BMS’ Orenica®) to develop and commercialise COYA302 on 20 March 2023.   Coya retains the right to commercialise COYA302 for patients with ALS in Japan, Mexico and South America. Coya will have responsibility for the clinical development of COYA302 and for seeking regulatory approval in US.

December 6, 2023

SystImmune and Bristol Myers Squibb announced that they have entered into an exclusive  global license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate.  Under the agreement the companies will jointly develop and commercialise BL-B01D1 in the US.  SystImmune through its affiliates will be responsible for development, manufacturing and commercialisation in China and will be responsible for manufacturing certain drug supplies for use outside of China.  BMS will be responsible for development and commercialisation of BL-B01D1 in the rest of the world.

BL-B01D1 is currently being evaluated in a global phase I study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC).

December 5, 2023

Bristol Myers Squibb (BMS) announced that the FDA has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  The FDA assigned a PDUFA goal date of 5 April 2024.

On 30 October 2023, the European Medicines Agency validated BMS’s type II variation application for Opdivo® for the above condition.

December 4, 2023

The Canadian Federal Court has refused AbbVie’s application for a permanent injunction against JAMP for exploitation of Simlandi® until the expiration of AbbVie’s Humira® patent no. 2,904,458.  Despite JAMP conceding it infringed the ‘458 patent, it successfully argued that the injunction should not be granted for public interest reasons.  It argued that: 

  • there was an alternative remedy available (a reasonably royalty paid by JAMP to AbbVie); 
  • Humira® would not benefit from additional sales if Simlandi® was removed from the market as Simlandi® patients would be switched to another biosimilar for which AbbVie is likely receiving a royalty;  
  • the removal of Simlandi® would deprive patients of the only 80 mg/0.8 mL formulation available in Canada; and 
  • if Simlandi® and Yuflyma® (Celltrion) are removed, all Simlandi® patients will have to switch to a biosimilar with a higher injection volume and possibly citrate, which could increase injection site pain for these patients and cause them harm. 

The Court also found that two of AbbVie’s Humira® dosing regimen patents (nos. 2,504,868 and 2,801,917)were invalid for obviousness.  

December 3, 2023

Roche and Carmot Therapeutics announced a US$2.7B agreement for Roche to acquire Carmot Therapeutics, including its R&D portfolio of clinical stage incretins.  The deal also provides for potential additional milestone payments of up to US$400M.

As part of the acquisition, Roche will acquire:

  • CT-388, the lead asset, a Phase-2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes;
  • CT-996, a small molecule GLP-1 receptor agonist currently in Phase-1 intended to treat obesity in patients with and without type 2 diabetes; and
  • CT-868, a Phase-2, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity.

On 9 May 2023, Roche acquired worldwide rights to Zion Pharma’s ZN-A-1041 (oral HER2 TKI).

December 1, 2023

New Zealand’s Pharmac has listed Celltrion’s Herzuma®, biosimilar to Genentech’s Herceptin®, on the Pharmaceutical Schedule for the treatment of breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology). Patients taking Herceptin® will need to move to Herzuma® by 1 June 2024 as Herceptin® will be delisted from the Schedule.

December 1, 2023

The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its biosimilar to Amgen’s Prolia® (denosumab) for the treatment of osteoporosis and related diseases.  The KBR reported that Celltrion has confirmed CT-P41’s equivalence and similarity in a phase III trial, and is seeking approval as an interchangeable biosimilar.

December 1, 2023

Syngene announced that it has completed the acquisition of a biologics manufacturing facility from Stelis Biopharma (a subsidiary of Strides Pharma Science, located in Bangalore).  Sygene announced the acquisition in July 2023.

November 30, 2023

Samsung announced that has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 February 2025.

Samsung and J&J subsidiary Janssen previously made reference to a settlement (without reference to the licence date) in their joint motion dated 3 August 2023, to terminate Samsung’s Inter Partes Review (IPR) challenging Janssen’s US patent 10 961 307.

Samsung’s BLA for SB17 is under review with the FDA and if approved will be commercialised in the US by Sandoz.

J&J has also entered into ustekinumab settlements with Celltrion (with a US licence date of 7 March 2025), Fresenius Kabi and Formycon (with a US licence date no later than 15 April 2025), Alvotech and Teva (with US licence date no later than 21 February 2025) and Amgen (with a US licence date no later than 1 January 2025).

November 30, 2023

Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.  The FDA has set a target action date of 9 May 2024.

November 29, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Formycon asserting infringement of 39 US aflibercept patents.  The heavily redacted Complaint states that on 29 August 2023 Formycon announced its aBLA for FYB203 was accepted for review by the FDA, and that this constitutes patent infringement.  The Complaint also states on information and belief that on 30 August 2020 Formycon imported or directed the importation at least one shipment of FYB203 into the US.

This is Regeneron’s fourth aflibercept complaint filed in the US District Court for the Northern District of West Virginia.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

November 29, 2023

Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint.  The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.

Alvotech announced the study in January 2023.  In May 2023, Alvotech announced a study in adult patients with moderate to severe rheumatoid arthritis.

November 29, 2023

Bio-Thera Solutions announced that its phase III study of BAT2206 demonstrated it is highly similar to Janssen’s Stelara® (ustekinumab) in patients with moderate to severe plaque psoriasis.  Bio-Thera confirmed it will present the results at a future medical meeting or in a publication.

On 16 June 2023, Bio-Thera entered a distribution agreement for BAT2206 in Brazil.  In 2021 Bio-Thera entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

November 28, 2023

Samsung Biologics disclosed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has taken ₩3T (US$2.3B) in orders in 2023 after it has entered a new confidential sales/supply contract worth ₩588B (~US$457M).  The contract partner and contract period will be disclosed after 31 December 2025 for confidentiality reasons.

On 25 October 2023, Samsung Biologics announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.

November 28, 2023

Daiichi Sankyo announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Daichirona® for IV injection as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19.  Daichirona® is the first Japanese-made mRNA vaccine, and will be distributed in the coming days in Japan.

On 19 October 2023, Daiichi and Merck announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan.

November 28, 2023

Alvotech reported unaudited financial results for the first nine months of 2023.  Results included product revenue of US$29.8 million in 2023 compared to US$11.1 million for the same period in 2022, and R&D expenses of US$152.8 million compared to US$133.1 million in 2022.  The 2023 revenue consisted of European and Canadian sales of AVT02, Alvotech’s Humira® (adalimumab) biosimilar.

Alvotech also announced that it has resubmitted its BLA for AVT04 Stelara® (ustekinumab) biosimilar, which the FDA has accepted for review with a BsUFA goal date of 16 April 2024.  It also reported highlights including the FDA’s acceptance for review of its resubmitted BLA for AVT02 with a goal date of 24 February 2024, as well as marketing approvals for AVT04 in Canada and Japan, and a positive CHMP opinion in Europe.

November 28, 2023

Biocon Biologics announced that it has completed the integration of Viatris in 31 countries in Europe.

Biocon Biologics completed the US integration in September 2023.  The multi-billion dollar deal was finalised in November 2022.

November 27, 2023

Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion announced it also applied for EU approval of its aflibercept biosimilar CT-P43.  On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

November 27, 2023

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinical trials.

On 20 October 2023, Sanofi and Regeneron received a complete response letter from the FDA regarding its sBLA for Dupixent® for its use in chronic spontaneous urticaria.

November 27, 2023

Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®, to treat wet AMD.  On 29 September 2023 Outlook Therapeutics requested a Type A meeting with the FDA (an immediately necessary meeting for a drug development program to proceed).  The FDA confirmed in the Type A meeting that Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months.

In the CRL dated 30 August 2023, the FDA acknowledged the Outlook NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

November 24, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the positive results from Celltrion’s Ph III trials of CT-P42 which were reported on 3 April 2023.

November 24, 2023

Express Pharma reported that Enzene Biosciences has launched its biosimilar ranibizumab in India (biosimilar to Genentech’s Lucentis®) for the treatment of neovascular age-related macular degeneration (AMD).  This is Enzene’s seventh Indian biosimilar.

On 7 September 2023, we reported that Enzene would ‘imminently’ launch its biosimilar ranibizumab.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

November 22, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against Janssen’s US patent no. 10,961,307 relating to Stelara® (ustekinumab).  Biocon Biologics is challenging all 34 claims of the patent, relating to methods of treating ulcerative colitis with ustekinumab.

On 9 August 2023, the USPTO Patent Trial and Appeal Board terminated Samsung Bioepis’s IPR challenging the ‘307 patent following Samsung and Janssen’s joint motion for termination on the basis that the parties had resolved the dispute.

November 22, 2023

Chugai Pharmaceutical announced the Japanese launch of Phesgo®, a subcutaneous combination of pertuzumab and trastuzumab (Genentech’s Perjeta® and Herceptin® respectively) to treat HER2-positive breast cancer and advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.

The Japanese National Health Insurance (NHI) reimbursement price list included Phesgo® on the day Chugai launched it. Phesgo® was approved by the Ministry of Health, Labour and Welfare on 25 September 2023.

November 22, 2023

A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab).  The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and had comparable pharmacokinetic, safety and immunogenicity profiles to Stelara®. 

In April 2023, Celltrion filed an application in Australia seeking approval of CT-P43 for all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. 

November 21, 2023

Sandoz has launched its high concentration formulation (100mg/ml) of Hyrimoz® in Europe, biosimilar to AbbVie’s Humira® (adalimumab).  This citrate-free high concentration formulation is indicated for all conditions for which Humira® is supplied.

Hyrimoz® was granted marketing authorisation in the EU on 3 April 2023.  The same formulation was approved by the FDA on 21 March 2023.

November 21, 2023

BeiGene and Ensem Therapeutics announced that BeiGene will acquire Ensem’s investigational new drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor as part of an exclusive global licensing deal.  Ensem will receive an upfront payment and is eligible for additional payments upon achievement of development, regulatory, and commercial milestones, totalling up to US$1.33B. Ensem will also receive tiered royalties.

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties.

November 21, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents.  The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologics Drug Application (aBLA) for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.  However, the Complaint states on information and belief that between 2 July 2019 and 8 June 2023 Samsung entities imported or directed the importation into the US of 36 shipments of SB15.

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents: US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 in April 2023, US10,888,601 in April 2023 and US10,130,681 in January 2023.

November 21, 2023

On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab).

The Federal Court decision was handed down in July 2023.

November 20, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against  certain claims of Regeneron’s US patent no. 10,888,601 relating to Eylea® (aflibercept).  The challenged claims relate to methods of treating diabetic macular edema and diabetic retinopathy.  Biocon Biologics’ petition asserts the same grounds as the earlier petition filed by Samsung Bioepis and instituted by the USPTO Patent Trial and Appeal Board (PTAB) in March 2023, and includes a motion for joinder with Samsung’s petition.

November 20, 2023

AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of treatment patents.  The alleged infringements arise from the respondents’ respective submissions of Abbreviated Biologic License Applications (aBLA) to the FDA seeking approval of their Rinvoq® biosimilars.

AbbVie is seeking injunctions preventing the supply of the upadacitinib biosimilars, and damages.  AbbVie has also sought orders that the effective date of any FDA approval of the respondents’ ANDAs be no earlier than the last expiry date of the allegedly infringed patents (with the earliest expiring patent on 9 June 2029, and the latest expiry is 9 March 2038) or any later exclusivity expiry.

On 18 May 2023, the FDA approved an expanded indication for Rinvoq® to include adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers.

November 20, 2023

Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Switzerland.  Sam Chun Dang will receive up to €20M from the unnamed distributor, with the agreement implementing a 50% profit share arrangement.

On 24 August 2023, Sam Chun Dang licenced SCD411 to Apotex for Canada.

November 20, 2023

CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.

CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars).  There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.

CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®.   CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.

November 17, 2023

Almirall announced that its received marketing authorisation from the European Commission (EC) for Ebglyss® (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Almirall will first launch Ebglyss® in Germany and continue distribution in other European countries in 2024.  Almirall licensed the rights to develop and commercialise lebrikizumab in Europe for dermatology indications from Dermira in June 2019, which was acquired by Eli Lilly in January 2020.  Eli Lilly has exclusive rights for Ebglyss’® development and commercialisation in all other jurisdictions outside of Europe.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Ebglyss® to treat moderate and severe forms of atopic dermatitis in adults and adolescents.

November 17, 2023

Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey.  The alleged infringement arises from Dr Reddy’s submission of its Abbreviated Biologic License Application (aBLA) to the FDA seeking approval for DRL_RI, its Rituxan® biosimilar.  The originators allege that Fresenius assisted Dr Reddy’s in its aBLA application.

On 12 July 2023, Dr Reddy’s announced its BLA for DRL_RI was accepted for review by the FDA following acceptance of its DRL_RI dossier by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) filed in April 2023.

November 17, 2023

EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers.  On 30 April 2019, Sandoz and EirGenix inked a deal under which EirGenix develops & makes Herwenda®, and Sandoz commercialises the biosimilar on approval for all regions other than Taiwan, China, Russia, and some Asian countries.

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Herwenda®.

November 17, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 11,253,572 in IPR proceeding IPR2023-00884.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

November 16, 2023

AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).  Patients will be eligible to receive Truqap® if they have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. 

On 14 November 2023, AZ announced that China’s NMPA approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine and cisplatin). 

November 16, 2023

Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies or biologics. 

On 28 August 2023, AbbVie submitted applications to the EMA and FDA for Skyrizi® to treat moderately to severely active ulcerative colitis. 

November 16, 2023

Merck announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.   

On 7 November 2023, the FDA revised the existing indication for Keytruda® for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ).

November 15, 2023

The French Parliament is debating 2024 budget reform (Social Security Financing Bill for 2024) which would enable pharmacists to substitute originator biologic products with biosimilars two years after the launch of the biosimilarUnder proposed amendments 1156, 2415 and 663, substitution could occur unless the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) objectsThe proposed reforms align with the European Medicines Agency April 2023 opinion regarding the interchangeability of biosimilars. 

November 15, 2023

Bristol Myers Squibb (BMS) announced the FDA approved its Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).  

On 30 October 2023, FDA approved BMS’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older. 

November 15, 2023

The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab).  Samsung appears to be ahead of several other companies in its pembrolizumab biosimilar clinical programme, noting that Samsung must commence its trial within a year of the approval.  Formycon, Xbrane and Celltrion previously announced that they have pembrolizumab biosimilars in development.  Formycon reported in its nine-month financial results for 2023 that its pembrolizumab clinical programme will commence in 2024Xbrane reported in its financial reports for Jan-Jun 2023 that its pembrolizumab biosimilar candidate, Xtrudane™, is in preclinical development.  Celltrion has not provided an update on the status of its development. 

November 14, 2023

Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada.  AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada.  The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)).  The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.

November 14, 2023

Roche announced that the EU CHMP recommended the approval of its subcutaneous (SC) formulation of Tecentriq® (atezolizumab).  The CHMP recommended Tecentriq SC for all indications for which Tecentriq® is approved, including various lung, liver, bladder and breast cancers.

On 27 October 2023, Roche received a new indication approval by FDA  for the use of Vabysmo® (faricimab) to treat macular oedema following retinal vein occlusion. 

November 14, 2023

AstraZeneca announced that China’s National Medical Products Administration (NMPA) approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin). 

On 22 February 2023, the European Commission approved Imfinzi® and tremelimumab immunotherapy combination to treat advanced liver and lung cancers. 

November 13, 2023

Biocon Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), to treat neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation This follows the 20 September 2023EC marketing approval Biocon Biologics secured for Yesafili®. 

November 13, 2023

The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®The company presented the final results of its 40 week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) 2023 conference in California.   
 
Celltrion reported its 24 week results from the study in April 2023, the same month it reported that it submitted its application to the EMA. 

November 10, 2023

Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), with treatment intervals of up to five months.

The US FDA approved 8mg Eylea® in August 2023.

Aflibercept 8 mg was jointly developed by Bayer and Regeneron.  Bayer reported that Regeneron has exclusive rights to Eylea 2mg and 8mg in the US, and Bayer has the exclusive marketing rights outside the US.

November 10, 2023

Alvotech and its EU partner Stada announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ustekinumab Uzpruvo (AVT04), biosimilar to Janssen’s Stelara®.  This is the first positive CHMP opinion for a Stelara® biosimilar.

The Alvotech and Stada MAA was accepted by the EMA in February 2023.

Under their 2019 strategic partnership for seven biosimilars, Alvotech is primarily responsible for developing and manufacturing AVT04, and Stada holds commercial rights within Europe.  In May 2023 Alvotech announced that it had terminated the Stada agreement with respect to three biosimilars (excluding ustekinumab), and entered into an agreement with Advanz for Europe for five biosimilars month.

November 10, 2023

Lupin Limited announced that it has executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE.

November 10, 2023

Biocon Ltd announced its consolidated financial results, including a 97% increase in revenue year on year for its biologics subsidiary, Biocon Biologics.  Biocon reported that this was largely driven by Biocon Biologics’ acquisition of Viatris’ biosimilars business and growth in market share for its biosimilar portfolio.

November 9, 2023

A pre-filled pen presentation of Janssen-Cilag’s Stelara® (ustekinumab) injection (90mg/1mL and 45mg/0.5mL) has been listed on the Australian Register of Therapeutic Goods.

November 9, 2023

Sandoz announced the inauguration of its new Biosimilar Development Center in Holzkirchen, Germany.  Sandoz invested €25 million in the Holzkirchen lab and received support from the Bavarian State government.  The lab will be a key site for Sandoz biosimilar development.

November 8, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents.  The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food and Drug Administration (FDA) on 30 June 2023 for CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.

The Complaint states that Celltrion has served a Notice of Commercial Marketing and that its aBLA may be approved as soon as 18 May 2024, the regulatory exclusivity expiry date for Regeneron’s Eylea®.

In March, the US PTAB instituted Celltrion’s IPR challenges to two of these patents, US 10,888,601 and US 10,130,681.

November 8, 2023

The FDA approved Eli Lilly’s Zepbound™ (Tirzepatide) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a specified initial body mass index (BMI).  Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.  Eli Lilly’s other tirzepatide product, Mounjaro™, was approved in May 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

November 8, 2023

Takeda announced that the US Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib) for the oral treatment of adults with Metastatic Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. This is the first US approval of fruquintinib.

November 7, 2023

Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab).  The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

Samsung Bioepis and Organon announced the interchangeability results for Hadlima™ in August .

The FDA has designated both Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and Pfizer’s Abrilada® as interchangeable biosimilars to Humira®.  The FDA has accepted Alvotech’s BLA for AVT02, its high concentration, interchangeable biosimilar, with a goal date of 24 February 2024.  Celltrion is also seeking an interchangeability designation for its approved biosimilar Yuflyma®, which it reported is tentatively expected in Q4 2024.

November 7, 2023

The Korea Economic Daily reported that Celltrion announced record quarterly earnings, with an operating profit of ₩276.6 billion, an increase of 25.2% the same period in 2022, and estimated profit and revenue respectively of ₩220 billion and ₩620 billion.  Celltrion’s key marketed products include biosimilars Yuflyma® (adalimumab), Remsima® SC/Zymfentra® (infliximab), Truxima® (rituximab) and Herzuma® (trastuzumab).

November 7, 2023

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy.  The updated indication is restricted to patients whose tumors express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.  Both the original and updated indication were approved under accelerated approval regulations.

The same indication was approved in Europe in August 2023, similarly limited to adults whose tumors express PD-L1 ( [CPS]≥1).

November 2, 2023

A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support mAbxience’s MB02 bioequivalence to Genentech’s Avastin® (bevacizumab) (EU and US).  No clinically meaningful differences in safety or immunogenicity were observed.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

November 1, 2023

Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU Tyenne® was approved by the EC on 19 September 2023 to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome and COVID-19.

November 1, 2023

Merck announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.  This brings the total number of US approved gastrointestinal-related indications for Keytruda® to six.

In October the FDA approved Keytruda® for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

October 31, 2023

Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938, its biosimilar to Regeneron’s Eylea® (aflibercept).  Amgen did not include the FDA target action date in its announcement.

On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

October 31, 2023

On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to Janssen’s Stelara®Wezlana is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (each in both adults and paediatric patients six years and older), and the treatment of moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (in adults)Wezlana® is a subcutaneous injection in a 45mg/0.5mL pre-filled syringe and a 45mg/0.5mL vial

October 31, 2023

Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

On 27 October 2023 the National Institute for Health and Care Excellence (NICE) recommended Cosentyx® for moderate to severe HS.

October 30, 2023

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products.   The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023.  The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.

October 30, 2023

The FDA has approved Bristol Myers Squibb’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older.

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.

October 30, 2023

Aragen announced it is establishing a new US$30M, 160,000m2 biologics manufacturing site in Bangalore, India.  The facility will include multiple GMP manufacturing suites, quality control and process development labs, and downstream purification capabilities.

On 12 October 2023, the Dr Reddy’s biologics manufacturing facility in Hyderabad was issued a Form 483 from the FDA.

October 30, 2023

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  This validation of the application confirms the submission is complete.

On 22 August 2023 the European Commission expanded the indication for Opdivo® as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.

October 28, 2023

Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued as part of a routine cGMP inspection of the facility by the FDA between 19 and 27 October 2023.  Dr Reddy’s confirmed in the announcement that it will address all ten observations within the stipulated timeline.

On 12 October 2023, the FDA issued a Form 483 with nine observations regarding that same Dr Reddy’s biologics manufacturing facility, after a product-specific pre-approval inspection by the FDA between 4 and 12 October. 

October 27, 2023

Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered in France.  Sanofi intends to focus on its biopharma business.

October 27, 2023

The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC meeting.  Documents include:

  • Cipla’s public summary document for Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvotech (AVT02);
  • Juno Pharmaceuticals’ public summary document for Exarane™ and Exarane Forte™ (Sanofi’s Lovenox®) (enoxaparin); and
  • Sun Pharma’s public summary document for Yonsa Mpred® (Janssen’s Zytiga®) (abiraterone and methylprednisolone).

October 27, 2023

Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal cancer (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Coherus acquired toripalimab from Surface Oncology last month on 8 September 2023.

October 27, 2023

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.

Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.  Vabysmo® was first  FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.

October 27, 2023

Novartis announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending Cosentyx® (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults in England and Wales.   It will be recommended for patients with an inadequate response to conventional systemic HS therapy and where adalimumab is not suitable.

On 6 October 2023 the FDA approved Novartis’ new intravenous formulation of Cosentyx® for the treatment of adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

October 26, 2023

It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture of FYB202, its Stelara® (ustekinumab) biosimilar, in Germany until expiry of Janssen’s SPC on its basic ustekinumab patent on 20 July 2024.  According to the reports, the decision reflected the arguments submitted by Janssen that in order to rely on the EU manufacturing waiver to export FYB202 before SPC expiry, Formycon was required to produce a relevant marketing authorisation in a country outside the EU in which the SPC was not in force, and had not done so.

FYB202 is not approved in the EU.  Formycon and its commercialisation partner Fresenius Kabi announced in September 2023 that their MAA for FYB202 has been accepted for review by the EMA.

October 26, 2023

Eli Lilly announced that the FDA has approved its Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

On 1 April 2023, Eli Lilly launched its insulin glargine (Rezvoglar®) biosimilar to Sanofi’s Lantus®, in the US.  

Omvoh® is currently being assessed by the TGA, and was accepted for assessment in July 2022.  It was also approved in the EU by the European Commission on 26 May 2023

October 25, 2023

Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.  Samsung attributed this revenue hike to an increase in the operating rate of Plant 4 and a sales backlog, resulting in a projected over 20% annual growth in consolidated revenue.

Throughout the quarter, Samsung Biologics also expanded its strategic partnerships to a value of over 11.8B and includes “14 of the top 20 global pharmaceutical companies further solidifying the company’s position as a trusted CDMO partner”.

Samsung will also open its new Plant 5 by April 2025, which will add an extra 180,000L of capacity.

On 24 October 2023, Samsung Biologics announced that it and European VC firm Kurma Partners entered a strategic partnership to develop and manufacture biologics for Kurma’s companies.

October 24, 2023

FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.  FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.

October 24, 2023

Samsung Biologics announced that it has entered a strategic agreement with European VC firm Kurma Partners to develop and manufacture biologics.  Samsung Biologics will provide chemistry, manufacturing, control and development services to Kurma’s companies under the multi-year deal.

On 18 September 2023, Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.

October 23, 2023

Roche, Genentech, Chugai and Biogen have settled their dispute in the US District Court for the District of Massachusetts regarding Genentech’s Actemra® (tocilizumab) patents.  Roche, Genentech and Chugai instigated proceedings on 23 July 2023, alleging that Biogen’s product, manufactured in China by Bio-Thera, infringed 20 US patents including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype).

Biogen received FDA approval for Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® on 30 September 2023, the only approved biosimilar tocilizumab in the US.

October 23, 2023

Celltrion announced that the FDA has approved its subcutaneous formulation of Zymfentra® (infliximab -dyyb), biosimilar to Janssen’s Remicade®, as maintenance treatment for ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an IV infliximab.  This is the first FDA approved subcutaneous formulation of infliximab.  Zymfentra® is marketed as Remsima SC® in Europe.

On 2 October 2023, Celltrion announced that the FDA approved Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosage forms.

October 23, 2023

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.  This will simplify the procedure for prescribers for obtaining authority to prescribe (ie an authority script) for certain biosimilar medicines which are reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS).   The affected medicines are:

The intention of these changes is to encourage greater use of biosimilars by easing the administrative burden for prescribers to obtain the necessary authority.  For initial therapy with a biosimilar, authority from Services Australia may be obtained by telephone or online with immediate effect, rather than in writing.  The requirement to obtain prior authority to prescribe the biosimilar for continuing therapy will be removed, with the requirement now ‘Authority Required (Streamlined)’.

For the rheumatoid arthritis medicines, in general brand substitution of a biosimilar with the reference brand will not be permitted where the approval was by telephone, online or by Streamlined prescription.  An exception applies for subsequent continuing therapy where substitution is permitted by the prescriber.

October 20, 2023

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approval, but did not identify any issues with safety or manufacturing.  The companies confirmed that the ongoing clinical trial is enrolling patients, and results are expected in late 2024.  According to Regeneron and Sanofi, these trials should provide the additional efficacy data required by the FDA.

On 11 July 2023 Sanofi received MA for Dupixent® in India to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.

October 20, 2023

The FDA has issued Samsung Biologics with a Form 483 containing six key observations following site inspections on 21-25, 28-31 August and 1 September 2023.  A Form 483 is issued to companies at the conclusion of an FDA inspection if conditions may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.  A Form 483 does not constitute a final FDA determination of violation of the FD&C Act or any relevant regulations.  Fierce Pharma has reported that Samsung is taking the FDA’s concerns seriously and has “developed a comprehensive plan” to address the manufacturing shortfalls swiftly.

October 20, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 10,888,601 in IPR proceeding IPR2023-00739.  The ‘601 patent relates to methods of use of aflibercept in treating age related macular degeneration, diabetic macular oedema, diabetic retinopathy and angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

October 19, 2023

The Korea Herald reported that Samsung Bioepis has launched Epysqli®, its biosimilar to AstraZeneca/Alexion’s Soliris® (eculizumab) in three European countries.  Samsung Bioepis confirmed it is preparing to launch Epysqli® in France and the Netherlands by the end of 2023.

Samsung Bioepis’ Epysqli® was approved by the EMA on 30 May 2023.

October 19, 2023

Merck and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and commercialise the candidates around the world, except for Japan, where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply.

Merck will pay Daiichi a US$4B upfront payment and US$1.5B in continuation payments over the next 24 months. Contingent on Daiichi meeting future milestones, Merck may make additional payments of up to US$16.5B, reaching a total potential consideration of up to US$22B.

On 18 October 2023, the EC approved AstraZeneca/Daiichi’s (trastuzumab deruxtecan) for a new indication as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer.

October 18, 2023

AstraZeneca and Daiichi Sankyo announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The EMA’s CHMP recommended the indication extension for Enhertu® on 15 September 2023.

October 18, 2023

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD).  Soliris® is the first and only complement inhibitor approved for the treatment of NMOSD in China.

On 24 August 2023 Soliris® was approved in Japan for a new indication to treat paediatric patients with generalised myasthenia gravis.

October 18, 2023

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/originator outcomes found that Biogen’s Benepali® and Novartis’ Erelzi® demonstrated comparable efficacy to Enbrel®.   Erelzi® was the first etanercept biosimilar approved by the FDA on 30 August 2016, with  Samsung Bioepis’ Eticovo® (marketed as Benepali® in Europe) receiving FDA approval on 25 April 2019.

October 17, 2023

On 17 October 2023, AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib) to for new indication: moderate to severely active Crohn’s disease.  This follows the recent Canadian approval (9 May 2023), of Rinvoq® for the treatment of Active Non-Radiographic Axial Spondyloarthritis.

The FDA approved Rinvoq® for moderate to severely active Crohn’s disease on 18 May 2023.

October 16, 2023

AstraZeneca announced that the FDA accepted for Priority Review its supplemental New Drug Application (sNDA) for Tagrisso® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The FDA expects to decide on the sNDA by Q1 2024.

Last month on 5 September 2023, AZ announced that the Chinese National Medical Products Administration approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy.

October 16, 2023

Korea Biomed has reported that US pharmacy provider CarePartners Pharmacy will exclusively supply Celltrion’s biosimilar adalimumab (Yuflyma®) in the US.  It has removed AbbVie’s Humira® from its product line.  The partnership will be relevant to the supply of adalimumab to more than 10 million patients linked with CarePartners.

On 5 October 2023, Celltrion USA announced that Ventegra® listed Yuflyma® as a “preferred drug” from early October 2023.

October 16, 2023

Merck made two announcements regarding new indications approved for Keytruda® (pembrolizumab):

  • In the US the FDA granted approval for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. This brings the total number of NSCLC-related indications for Keytruda® in the US to six.
  • In Europe the European Commission (EC) granted approval for Keytruda® as a monotherapy for the adjuvant treatment of adults with SCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

October 16, 2023

A Zhejiang Hisun Pharmaceuticals sponsored study published in Frontiers in Pharmacology has found that HS016, biosimilar to AbbVie’s Humira® (adalimumab) was safe and effective in Chinese inflammatory bowel disease (IBD) patients.

Hisun completed its stage III clinical trials of HS016 back in early 2020.

October 15, 2023

Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.  The SB16 ph I and III studies demonstrate respectively pharmacokinetic bioequivalence and biosimilarity of SB17 to reference denosumab.

October 15, 2023

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease. 

October 15, 2023

A new study abstract published in United European Gastroenterology concluded that patients who switched from Celltrion’s Remsima® (CT-P13) to Samsung Bioepis’ Flixabi®/Reflexis® (SB2), both biosimilars to Janssen’s Remicade® (infliximab) was safe, did not significantly affect effectiveness or pharmacokinetics, and was not associated with major negative psychological implications.

On 26 May 2023, a study published in JAMA Network Open found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics.

October 13, 2023

Merck announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

This will be the second indication for Keytruda® for the first-line treatment of such cancers in EU, following approval of Keytruda® in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy in August 2023.

October 12, 2023

Dr Reddy’s informed the Indian National Stock exchange on 12 October 2023 that the FDA issued a Form 483 with nine observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued after a product-specific pre-approval inspection of the facility by the FDA between 4 and 12 October 2023.

October 12, 2023

Prince Edward Island announced implementation of a biosimilar switching policy consistent with ten other provinces in Canada.  From 12 October 2023, patients covered under PEI Pharmacare program will begin switching biosimilars. Pharmacare beneficiaries will have until 30 June 2024 to work with healthcare providers to switch to a biosimilar.  Patients currently using Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade® or Rituxan® will be transitioned to a biosimilar version by 30 June 2024 to maintain their coverage.

We reported on previous Canadian announcements of Biosimilar switching initiatives, including Newfoundland and LabradorYukon, Ontario, British ColumbiaAlbertaNew BrunswickQuebec, Northwest Territories, Nova Scotia and Saskatchewan.

October 12, 2023

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facility in March 2023.  No other deficiencies were noted by the FDA.  Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly.  This will likely trigger a new BsUFA date for Alvotech’s ustekinumab.

In June 2023 Alvotech and Teva (the exclusive commercialization partner for AVT04 in the US), reached a settlement and license agreement with Johnson & Johnson that grants an entry date for AVT04 in the US no later than 21 February 2025.

On 25 September 2023 Alvotech received approval in Japan for AVT04.

October 12, 2023

Amneal Pharmaceuticals, Inc announced that it has added two denosumab products (biosimilars to Amgen’s Prolia® and Xgeva®) to its biosimilar pipeline.  The denosumab products are being developed by mAbxience.  MAbxience is responsibility for development and manufacture and Amneal is responsible for regulatory approval and has exclusive US commercialisation rights.

On 3 October 2022 Amneal Pharmaceuticals announced the US launch of another biosimilar developed by mAbxience: Alymsys® (biosimilar bevacizumab).

October 11, 2023

Samsung Bioepis presented new data on its SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) and Imraldi® (adalimumab, biosimilar to AbbVie’s Humira®) at the European Academy of Dermatology and Venereology (EADV) Congress.  The SB17 phIII study demonstrates that SB17 has equivalent efficacy and comparable safety and PK to Stelara® up to week 28 in patients with moderate to severe plaque psoriasis.  The Imraldi® four-year follow up study indicates that Imraldi can be started or transitioned from AbbVie’s Humira® (adalimumab) in patients with moderate-to-severe psoriasis.

On 11 September 2023, Sandoz and Samsung Bioepis entered an exclusive commercialisation agreement for SB17 in the US, Canada, EEA, Switzerland and the UK.

October 10, 2023

Samsung Bioepis released its third US Biosimilar Market Report.  The quarterly report details recent prices of all biosimilars based on Q4 2023 average sales price (ASPs) published by the Center of Medicare, Medicaid Services (CMS), and market share and price trends of all biosimilars.

The report explores three key influences on biosimilar utilisation:

  1. Independent Medical Guidelines (noting that the influence of respected medical societies on biosimilar use ‘cannot be overstated’)
  2. Duration of Treatment: Acute vs. Chronic Conditions (HCPs are often reluctant to initiate changes in chronic patients who respond well to the medicine)
  3. Access and Rebate Walls (the impact of ‘grandfathering’ allows many patients to continue existing treatment even where biosimilars are available)

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that   biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023.

October 7, 2023

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

October 7, 2023

Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its BLA for its insulin aspart (biosimilar to Novo Nordisk’s NovoLog®).  The letter did not identify any outstanding scientific issues with the product, but references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection of the Biocon Malaysia facility.

On 20 September 2023, Biocon Biologics’ Yesafili®,biosimilar to Regeneron’s Eylea® (aflibercept), received marketing approval from the European Commission.

October 6, 2023

Novartis announced that the FDA has approved its new intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

On 1 June 2023, Novartis announced that the European Commission approved Cosentyx® for a new indication to treat active moderate to severe hidradenitis suppurativa in adult patients who have had an inadequate response to conventional systemic HS therapy.

October 5, 2023

Pfizer announced that the FDA has designated Abrilada® as the second interchangeable biosimilar to AbbVie’s Humira® (adalimumab), Following BI’s Cyltezo®.  The designation applies to all approved Abrilada® indications.  Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was the first approved  interchangeable adalimumab biosimilar on 15 October 2021.

The FDA accepted Pfizer’s sBLA for interchangeability for its adalimimab biosimilar Abrilada® on 25 February 2022, with a BsUFA goal date in Q4 2022.

October 5, 2023

Celltrion USA announced that large Medical Benefits Manager Ventegra, will add Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) to its formulary as a “preferred drug” by ‘the first part of October 2023’.

On 2 October 2023, Celltrion announced that it received FDA approval for two additional dosages of Yuflyma®.

October 5, 2023

Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

On 4 October 2023, Coherus announced its sales of Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis® surpassed 100,000 doses in its first year.

October 5, 2023

Thermo Fisher Scientific announced that it has expanded its St Louis biologics manufacturing facility, adding up to four Thermo Scientific™ bioreactors, each of which can process up to 5,000 liters.

October 4, 2023

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® for all approved indications.

On 5 October 2023, Coherus resubmitted its BLA to the FDA for Udenyca® OnBody™, biosimilar to Amgen’s Neulasta® after receiving CRL.

October 4, 2023

Novartis announced it successfully completed the spin-off of Sandoz, its former generics and biosimilars business on 4 October 2023.  Sandoz also made its own announcement about the spin-off, noting it completed its first trading day on the Swiss Exchange on 4 October with an opening share price of CHF 24.00.

The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 and secured shareholder approval for the spin-off at the Novartis EGM on September 15 2023.

October 3, 2023

A PLOS One study found that there was no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. The study examined unique studies and switch treatment periods for each reference biologic with an FDA approved biosimilar, including AbbVie’s Humira® (adalimumab), Amgen’s Epogen® (epoetin-alfa), Amgen’s Enbrel® (etanercept), Amgen’s Neupogen® (filgrastim), Sanofi’s Lantus® (insulin-glargine), Genentech/Biogen’s Rituxan® (rituximab) and Genentech’s Herceptin® (trastuzumab).

On 26 May 2023, a study published in JAMA Network Open found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics.

October 3, 2023

An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.  

On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.   

October 3, 2023

Alvotech announced it has partnered with Kashiv Biosciences for an exclusive licensing agreement concerning AVT23 (ADL018), a proposed biosimilar to Novartis/Genentech’s Xolair®, extending across 27 EU countries, the UK, Australia, Canada, and New Zealand.  Alvotech will receive exclusive commercialization rights, and Kashiv will oversee development and manufacturing.

On 2 October 2023, Kashiv announced it had enrolled its first patient in a phase III study for ADL018.

October 2, 2023

The Nobel Assembly at Karolinska Institutet awarded the 2023 Nobel Prize in Physiology or Medicine jointly to Katalin Karikó and Drew Weissman for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19.   Karikó and Weissman noticed that dendritic cells recognise in vitro transcribed mRNA as a foreign substance, which leads to their activation and the release of inflammatory signaling molecules.  They produced different variants of mRNA, each with unique chemical alterations in their bases, which abolished the inflammatory response by the cells and paving the way for the use of mRNA as a therapy.  

Recently on 11 September 2023, the FDA approved Pfizer & BioNTech’s 2023-2024 COVID-19 vaccine. 

October 2, 2023

Kashiv Biosciences announced that it has enrolled its first patient in a phase III clinical study of ADL018, its biosimilar to Novartis/Genentech’s Xolair® (omalizumab).  The objective of the study is to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamine treatment (NCT05774639).

On 30 June 2023, Kashiv completed a Phase I clinical trial for ADL-018.

October 2, 2023

FDA has approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

The Celltrion 80mg adalimumab auto-injector and pre-filled syringe were approved by Healthcare Canada on 30 August 2023.

October 2, 2023

Boehringer Ingelheim announced that its unbranded interchangeable biosimilar to AbbVie’s Humira®, is now available at a low wholesale acquisition cost, at a 81% discount to Humira®.  It is also available under the brand name Cyltezo® priced at a 5% discount to Humira®.

Cyltezo® was licensed for supply in the US on 1 July 2023 pursuant to the Boehringer and AbbVie settlement of the ongoing patent dispute on 15 May 2019.

October 1, 2023

Viatris announced it has received an offer for divestiture of most of its Over-the-Counter (OTC) business from Cooper Consumer Health, and has entered into agreements to divest its Women’s Healthcare business (oral and injectable contraceptives) to Insud Pharma, women’s healthcare products Duphaston® and Femoston® to Theramex, and its Active Pharmaceutical Ingredients business to Iquest Enterprises.  It has also agreed to divest commercialisation rights in particular non-core markets that were previously acquired.

On 6 September 2023, Biocon Biologics completed its integration of Viatris in North America.  The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

September 29, 2023

Biogen announced that the FDA has approved Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® (tocilizumab) for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  Tofidence® is the first FDA approved tocilizumab biosimilar.

On 19 September 2023, the European Commission approved Fresenius Kabi’s Tyenne®, also a biosimilar to Roche’s Actemra® / RoActemra®, which is the first EU approved biosimilar to tocilizumab.

September 29, 2023

Outlook Therapeutics announced that it requested a Type A meeting with the FDA to discuss its Complete Response Letter (CRL) regarding its BLA for ONS-5010, the first ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®.  In the CRL dated 30 August 2023, the FDA acknowledged the NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

September 29, 2023

Formycon and its commercialisation partner Fresenius Kabi announced that the EMA has accepted for review their MAA for FYB202, biosimilar to Johnson & Johnson’s Stelara® (ustekinumab).

In February 2023, Fresenius Kabi and Formycon AG announced they had reached a global agreement to commercialise FYB202. Under the agreement, Fresenius has exclusive commercialisation rights in key global markets, whilst Formycon is responsible for development and registration.  Formycon acquired the rights to FYB202 from Athos in May 2022.

September 29, 2023

ProciseDx announced that its Procise ADL and Procise IFX therapeutic drug monitoring tests for adalimumab (AbbVie’s Humira® and Amgen’s biosimilar Amgevita®) and infliximab (Janssen’s Remicade® and biosimilars Inflectra® (Pfizer) and Renflexis® (Organon)) have received FDA marketing authorization. The tests quantify levels of adalimumab or infliximab in patients with inflammatory bowel disease (IBD) based on time-resolved fluorescence resonance energy transfer immunoassays using the ProciseDx Analyzer and Lumiphore chemistry.

September 26, 2023

Coherus Biosciences announced that the FDA issued a Complete Response Letter (CRL) for its BLA for Udenyca® OnBody™, Coherus’ on-body injector presentation of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The letter relates to an ongoing review of inspection findings at a third-party filler.  The FDA did not identify issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing.

Separately, on 8 September 2023, Coherus announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.

September 26, 2023

Sandoz and Polpharma Biologics announced that the EC has approved Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, as a single disease-modifying therapy (DMT) in adults with highly active Relapsing Remitting Multiple Sclerosis. This is the first EC approved biosimilar to Tysabri®.  Tyruko® was developed by Polpharma Biologics, and will be commercialised by Sandoz.

Tyruko® was approved by the FDA on 25 August 2023. The EU CHMP issued a positive opinionrecommending approval of Tyruko® on 21 July 2023. 

September 25, 2023

Novartis confirmed its Sandoz generics and biosimilars business will spin-off, with trading of the new Sandoz Group AG to commence on 4 October 2023.

This follows the Novartis shareholder approval for the spin-off at its EGM on September 15 2023.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 with a target date of Q4/23.

September 25, 2023

KED Global reported that Celltrion Inc. will provide biosimilars worth ₩423.6B (US$323M) to its global sales and marketing affiliate Celltrion Healthcare Co., Celltrion’s largest supply deal.  The supplies include Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®), Remsima® and Remsima SC® (infliximab “biobetter” to Janssen’s Remicade®), Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®), and Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®).

On 18 September 2023, Celltrion won bids to supply Yuflyma® in five regions of Italy, and On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.

September 25, 2023

Eisai and Biogen announced that Leqembi® (lecanemab) intravenous infusion was approved in Japan for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD). On 21 August 2023, the Japanese Ministry of Health, Labour and Welfare committee recommended approval of Leqembi®.

Japan is the second country to grant approval of Leqembi®, following the traditional US FDA approval on 6 July 2023.

September 25, 2023

AbbVie announced that the EC granted conditional marketing authorisation for Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly® was co-developed by AbbVie and Genmab, and the companies share commercial responsibilities in the US and Japan.  AbbVie is responsible for further global commercialization and will continue to pursue regulatory submissions for the drug in international markets throughout 2023.

September 25, 2023

Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received marketing approval for AVT04 (ustekinumab), a biosimilar to Janssen’s Stelara®, from the Japanese Ministry of Health, Labor and Welfare.  Alvotech reported that, based on publicly available information this is the first ustekinumab biosimilar approved in Japan, and is also the first biosimilar approved under its agreement with Fuji which covers the commercialisation of seven biosimilars in total in Japan.

Alvotech and Fuji Pharma announced their exclusive agreement for the commercialisation of a Stelara® biosimilar in Japan in April 2019.

September 22, 2023

Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a non-binding MOU with Aurigene Pharmaceutical Services, a wholly-owned subsidiary of Dr Reddy’s Laboratories.  The Korea Economic Daily reported that Prestige Biologics will act as the primary manufacturing, packaging, and distribution hub in South Korea for Dr. Reddy’s extensive biopharmaceutical pipeline. Prestige plans to commence technology transfer next month in order to commence production immediately following execution of product-specific supply agreements.

On 12 July 2023, Dr Reddy’s announced that its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) will be reviewed by several global regulatory authorities, including the US FDA, EU EMA and UK MHRA.

September 21, 2023

Meitheal Pharmaceuticals announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars (insulin aspart, insulin lispro and insulin glargine) in the US. Under the agreement, Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical has the exclusive rights to commercialise the three biosimilars.  Meitheal anticipates regulatory approval of each of the biosimilars in around 2026.

On 1 April 2023, Eli Lilly launched its insulin glargine Rezvoglar®, biosimilar to Sanofi’s Lantus® in the US.

September 20, 2023

Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.  The first molecules will launch in 2025, while others are subject to further clinical development and registration. mAbxience will manufacture the biosimilars in Spain and Argentina, and will be responsible for achieving the clinical milestones for the molecules in development. Abbott will register and commercialise the biosimilars.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

September 20, 2023

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

This approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)  positive opinion for Yesafili® on 21 July 2023.

September 20, 2023

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024.  Alvotech stated that the FDA indicated that the resubmission, which incorporated  additional Chemistry, Manufacturing, and Controls information, is considered to be a completed response to the FDA’s Complete Response Letter (CRL) of 28 June 2023.  Alvotech announced on 13 April 2023 that it had responded to an earlier CRL received in March 2023.

On 31 August 2023, Alvotech announced that it had resubmitted the BLA for AVT02 to the FDA but did not disclose details or the BsUFA goal date.

September 20, 2023

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.  The FDA has set a PDUFA date of 20 January 2024.

September 19, 2023

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 2021.  BeiGene now has complete global rights to Tevimbra® without having to pay royalties to Novartis and will supply Novartis with Tevimbra® for its clinical trials.  Beigene stated that Novartis will assist BeiGene to ensure the smooth development and commercialisation of Tevimbra®, including manufacture, regulatory, safety, and clinical facets.

On 21 July 2023, BeiGene received a positive CHMP opinion for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

September 19, 2023

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19.  Tyenne® is the first biosimilar to Actemra® / RoActemra® approved by the EC.

The CHMP issued a positive opinion recommending approval of Tyenne® on 21 July 2023.

September 19, 2023

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

On 5 June 2023, Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.

September 18, 2023

Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.  The agreement expands the existing 10-year manufacturing deal signed in 2013, as Samsung Biologics will manufacture the commercial antibody at its latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea.

Recently, in July 2023, Samsung Biologics entered into agreement with Pfizer  worth US$897M to manufacture biosimilar products for oncology, inflammation and immunotherapy until 2029 in Plant 4.  Samsung also confirmed on 6 June 2023 that it will open its fifth manufacturing plant in April 2025.

September 18, 2023

The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling.  The guidance includes proposed recommended approaches for:

  • product identification, including when to use the biosimilar or interchangeable biosimilar product name, reference product name;
  • content presentation; and
  • specific sections of labeling, including prescribing information, indications, usage (including specific populations and paediatrics) and clinical pharmacology.

The draft document is open for comments by 17 November 2023.

September 18, 2023

KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five regions of Italy – accounting for approximately 20% of the Italian adalimumab market.  Yuflyma® recorded ₩54B (USD$40.7M) of sales in the first half of 2023, which Celltrion says is due to its expansion into Europe.

On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.

September 15, 2023

On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars business at its Extraordinary General Meeting.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 with a target date of Q4/23.

September 15, 2023

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®), to treat metastatic and early breast cancer and metastatic gastric cancer.

On the same day, Novartis’s shareholders approved the Sandoz spin-off which is scheduled for 4 October 2023.

September 15, 2023

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

CHMP also adopted a positive opinion for three new biologics:

  • Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
  • Novartis’ Finlee® (dabrafenib) to treat glioma; andlanadelumab
  • Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).

The CHMP recommended indication extensions for the following biologics:

  • Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
  • Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
  • Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
  • Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
  • Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
  • Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.

September 14, 2023

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

September 13, 2023

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.

On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.  Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

September 11, 2023

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows a confidential settlement in August 2023 between Samsung Bioepis and Janssen which resolved all pending disputes between the parties.  In that same month, Samsung Bioepis and Janssen filed a joint motion to terminate Samsung Bioepis’ IPR against Janssen’s US patent 10,961,307 filed 2 months earlier.

September 11, 2023

Pfizer and BioNTech announced that the FDA approved their sBLA for their 2023-2024 COVID-19 vaccine for patients over 12 years of age, and granted emergency use authorisation for patients from 6 months to 11 years old.  The vaccine is an omicron XBB.1.5-adapted monovalent vaccine indicated as a single dose for most patients over 5.

On 26 May 2023, Alnylam sued both Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines.

September 8, 2023

Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new clinical-stage assets, including:

  • Toripalimab: an anti-PD-1 monoclonal antibody under BLA review for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
  • CHS-006: a TIGIT-targeted antibody currently in a phase I / II study in combination with toripalimab in patients with advanced solid tumours;
  • Casdozokitug (SRF388 or casdozo): a first-in-class IL-27-targeted antibody in phase II clinical trials in lung cancer and liver cancer; and
  • CHS-114 (SRF114): an ADCC-enhanced CCR8-targeted antibody in a phase I / II study as a monotherapy in patients with advanced solid tumors.

On 2 August 2023, Coherus announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, had quadrupled to US$26.7M since the last quarter.

September 7, 2023

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

September 6, 2023

Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023.  The target date for the integration of Viatris was end Q3 2023.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’. The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

September 5, 2023

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

September 5, 2023

The Korea Economic Daily reported that Celltrion, Inc. announced plans to enlarge its finished pharmaceuticals manufacturing facility at its Songdo campus in Incheon, and has allocated about ₩126B (US$95M) for the project.  The expansion is scheduled to be completed by early 2026 and production to begin in 2027, with an annual production capacity of around 8 million liquid vials.

September 5, 2023

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

On 24 August 2023 AstraZeneca had Soliris® (eculizumab) approved in Japan for a new indication to treat paediatric patients with gMG.

September 1, 2023

Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for approval of CT-P43, its biosimilar to Janssen’s Stelara® (ustekinumab).   Celltrion applied for approval of all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Celltrion submitted its aBLA for CT-P43 to the US FDA in June 2023 (and reached a settlement and licence agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43 in the US on 7 March 2025), and submitted its MAA to EMA in May 2023.

September 1, 2023

Novartis has commenced proceedings in the Federal Court of New Jersey against the US Government two days after the Centers for Medicare and Medicaid Services (CMS) unveiled the first 10 drugs that will undergo new pricing negotiations with the US Government.  These pricing negotiations were introduced as part of President Biden’s Inflation Reduction Act 2022 (IRA).  Novartis’ Entresto® (sacubitril/valsartan) is subject to this first round of negotiations.  Novartis argues that the negotiations are ‘an unprecedented and unconstitutional attempt to compel the nation’s drug manufacturers to sell their products at prices dramatically below their market value’.

August 31, 2023

Alvotech announced in its 2023 Q2 Earnings Presentation that it has resubmitted its interchangeable BLA for AVT02, biosimilar to AbbVie’s high concentration Humira® (adalimumab). The company did not disclose the BsUFA date but anticipated launch in 2024.

The FDA issued a complete response letter (CRL) for Alvotech’s interchangeable BLA on 28 June 2023, noting issues at Alvotech’s facility in Reykjavik, Iceland.

Alvotech also reported that AVT04, its biosimilar to Stelara®, is filed and pending approval in 7 markets including U.S, EU, Japan, and Canada, and it is expecting some approvals to occur before end of 2023.

Alvotech published its financial results on 30 August 2023.

August 30, 2023

Outlook Therapeutics announced the FDA issued it with a Complete Response Letter (CRL) for its BLA for ONS-5010, biosimilar to Genentech’s Avastin® (bevacizumab). The FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, but could not approve the BLA due to several chemistry, manufacturing and controls issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

On 28 October 2022, the FDA accepted Outlook Therapeutics’ BLA for ONS-5010 for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

August 30, 2023

Celltrion Healthcare Canada announced that Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in an 80 mg auto-injector and pre-filled syringe. It is the only adalimumab biosimilar available at an 80 mg dose in an auto-injector.

On 1 July 2023, Yuflyma® became commercially available in the US after Celltrion obtained a licence from AbbVie on 27 April 2022.

August 30, 2023

Alvotech published its first half 2023 financial results, reporting a revenue growth to $22.7M for the six months ending 30 June 2023, compared to $3.9M for the same six months of 2022.  Revenue for that period consisted of product revenue from sales of AVT02 (Alvotech’s adalimumab biosimilar) in select European countries and Canada.  As of 30 June 2023 the company has $60.5M in cash/equivalents (excluding $25.2M in restricted cash) and current borrowings of $808.6M.  Its R&D costs for the six month period ending 30 June 2023 were $99.6M.

Recent highlighted reported included Alvotech’s expanded partnership with Advanz Pharma, adding five biosimilar candidates which Advanz Pharma will commercialise in Europe; Alvotech and Teva’s settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab); a complete response letter (CRL) from the US Food and Drug Administration (FDA) for Alvotech’s second Biologics License Application (BLA) for AVT02, an interchangeable high-concentration adalimumab biosimilar; and its expanded strategic partnership agreement with Teva, including exclusive commercialisation rights in the US by Teva for two new biosimilar candidates developed by Alvotech, as well as line extensions of two current biosimilar candidates.

August 29, 2023

The Patent Trial and Appeal Board (PTAB) issued decisions in Celltrion’s two inter partes reviews (IPRs) (IPR2022-00578 and IPR2022-00579), finding Chugai and Roche’s tocilizumab patents (US patent nos. 8,580,264 and 10,874,677) were invalid.  The PTAB found that claims 1-12 of the ‘264 patent were anticipated and/or obvious, and claims 1-8 of the ‘677 patent were obvious.

The PTAB instituted Celltrion’s two IPRs of Chugai and Roche’s tocilizumab patents on 31 August 2022.

August 29, 2023

The Korea Herald reported that Dong-A ST submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for its Stelara® biosimilar DMB-3115.  DMB-3115 was jointly developed by Dong-A and Meiji Seika Pharma, and will be commercialised in Europe by the Intas subsidiary Accord Healthcare.

Dong-A published the results of its global Ph III trials of DMB-3114 in January 2023.

August 29, 2023

Alvotech and Bioventure announced that AVT02, their biosimilar to AbbVie’s Humira® (adalimumab) has been approved (under brand name Adalimumab-EVA®) by the Egyptian Drug Authority.  Bioventure is Alvotech’s exclusive strategic partner for the commercialisation of AVT02 and other biosimilars in the Middle East and North Africa.

On 24 January 2023, Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and distribution of AVT02 under the brand name Simladi®.

August 29, 2023

Merck announced that the European Commission has approved a new indication for Keytruda® (pembrolizumab) – first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Scope [CPS]≥1), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy.

Merck stated that Keytruda® is the first immunotherapy approved in the EU for the first-line treatment of this patient population.  Keytruda is approved globally for the treatment of a large range of cancers.  In June 2022 the EC approved Keytruda® for expanded melanoma indications.

August 29, 2023

Formycon and Klinge Biopharma announced that the FDA has accepted for review the BLA for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).  The FDA has assigned a target action date of June 2024.

Formycon submitted the BLA for FYB203 in June 2023.  FYB203 is being developed by Formycon and will be commercialised by Klinge Biopharma.

August 29, 2023

The US Department of Health and Human Services (DHHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs selected for pricing negotiation as part of the Inflation Reduction Act 2022 (IRA).  The negotiations with the relevant pharmaceutical companies will occur in 2023 and 2024, and any price negotiations will come into force in 2026.

The ten drugs selected were:

  • Bristol Myers Squibb / Pfizer’s Eliquis® (apixaban)
  • Eli Lilly / Boehringer Ingelheim’s Jardiance® (empagliflozin)
  • Johnson & Johnson’s Xarelto® (rivaroxaban)
  • Merck’s Januvia® (sitagliptin)
  • AstraZeneca’s Farxiga® (dapagliflozin)
  • Novartis’ Entresto® (sacubitril/valsartan)
  • Amgen’s Enbrel® (etanercept)
  • AbbVie / Johnson & Johnson’s Imbruvica® (ibrutinib)
  • Johnson & Johnson’s Stelara® (ustekinumab)
  • Novo Nordisk’s Novolog®/Fiasp® (insulin aspart)

Only two days after this announcement, on 1 September 2023, Novartis brought proceedings against the US Government, arguing that these pricing negotiations are unconstitutional.  Other pharmaceutical companies have also sued the Government on this same legislation, including Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the industry group Pharmaceutical Research and Manufacturers of America.

August 28, 2023

AbbVie announced that it has submitted applications to the FDA and EMA for a new indication for Skyrizi® (risankizumab) to treat moderately to severely active ulcerative colitis (UC).  Skyrizi® is currently approved by both regulatory authorities to treat Crohn’s disease, psoriatic arthritis and psoriasis.

August 28, 2023

Bristol Myers Squibb announced that the FDA has approved Reblozyl® (luspatercept-aamt) to treat anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.  Reblozyl® is the first and only therapy that has demonstrated better patient outcomes compared to an ESA in MDS-related anemia.

On 1 May 2023, BMS announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application for Reblozyl® (luspatercept-aamt) to treat the above patient group.

August 26, 2023

A Biogen funded, pan-European study published in BioDrugs found that SB5 (Imraldi®), biosimilar to AbbVie’s Humira® (adalimumab), to be effective and well tolerated in patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and Crohn’s disease. The paper noted that “particular consideration should perhaps be given to female patients who are considering switching, since they appear to be more susceptible to discontinuation than their male counterparts”.

SB5 was first approved by the FDA on 24 July 2019; and was launched in the US by Samsung and Organon on 1 July 2023 as Hadlima® at a list price of $1038, an 85% discount compared to Humira®.  Biogen is commercialising SB5 as Imraldi® in Europe.

August 25, 2023

Korea Biomedical Review reported that Celltrion has finalised an agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43, its biosimilar to Stelara®, in the US on 7 March 2025.  Celltrion submitted its aBLA to the FDA in June 2023, and is seeking to obtain marketing authorisation in 2024.

This follows J&J’s ustekinumab settlements with Fresenius Kabi and Formycon (AG) (with a US licensed entry date no later than 15 April 2025), Alvotech and Teva (with a US licensed entry date no later than 21 February 2025), Amgen (with a licensed entry date no later than 1 January 2025) and with Samsung (for an unknown licensed entry date).

Celltrion filed its MAA with the EMA for CT-P43 in May 2023.

August 25, 2023

Sandoz announced that the FDA approved its biosimilar Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri, for all indications covered by Tysabri®.  It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).  Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

This news comes just a week after Sandoz announced its spin-off from Novartis is planned for 4 October 2023.  On 21 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion Tyruko® to treat active relapsing remitting MS.

August 24, 2023

AstraZeneca and Merck announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the indication for Lynparza® (olaparib), to be used alongside abiraterone and prednisolone for adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer showcasing distant metastasis (mCRPC).  Lynparza® is the first PARP inhibitor approved in Japan demonstrating significant benefits in tandem with a new hormonal agent.

On the same day AstraZeneca also announced the MHLW expanded approval for Soliris® (eculizumab) to treat paediatric patients with gMG.

August 24, 2023

AstraZeneca announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for the extended use of Soliris® (eculizumab) to treat paediatric patients suffering from generalised myasthenia gravis (gMG).  This approval specifically targets those who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control through high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).  Soliris® is the exclusive targeted therapy cleared for treating gMG in Japanese children and adolescents.

On the same day AstraZeneca also announced the MHLW expanded approval for it and Merck’s Lynparza® (olaparib) with abiraterone to treat BRCAm mCRPC.

August 24, 2023

Korea Biomedical Review reported that Sam Chun Dang Pharm has licensed its aflibercept biosimilar to Apotex for Canada.  Under the agreement, Sam Chun Dang Pharmaceutical will receive an upfront payment of approximately 4 billion South Korean won.  Additionally, Sam Chun Dang Pharmaceutical expects to receive up to 50% of the gross profit if the PFS product is the first to be listed on drug coverage plans, or if it is listed within three months of the first biosimilar aflibercept PFS product.  If the product is listed within 4-6 months of other biosimilar aflibercept PFS products, Sam Chun Dang will receive 35% of the gross profit.

August 23, 2023

Korea Biomed reported that Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on the formularies of over 10 US insurers since its US launch on 17 April 2023.  One of these includes a top-five insurer in terms of patient enrolment.  While the exact insurers’ names remain undisclosed, the recent listings mean Vegzelma® is now accessible to roughly 30% of the US population. Celltrion aspires to amplify its coverage to surpass 60% of Americans by early 2023.

On 11 May 2023, Celltrion began supplying Vegzelma® in Italy and Belgium.

August 23, 2023

CVS Health has launched Cordavis, a subsidiary that will work with manufacturers to commercialise and/or co-produce biosimilars for the US market.  Cordavis has a contract with Sandoz to commercialize and bring to market Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®, in Q1 of 2024 under a Cordavis private label.  The list price of the Cordavis Hyrimoz® will be more than 80% lower than the current list price of Humira®.

On 1 July 2023, seven biosimilars to AbbVie’s Humira® (adalimumab), including Sandoz’s Hyrimoz® launched in the US.  Sandoz announced its global adalimumab settlement with AbbVie on 11 October 2018.

August 23, 2023

Reuters has reported that Johnson & Johnson’s Janssen will close part of its vaccine research and development programs.  The restructuring was announced in J&J’s Q2 2023 financial results (see page 56), where it notes the R&D program exits are primarily in infectious diseases and vaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development.

August 23, 2023

Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved in Japan for a new indication: to treat unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.

On 12 July 2023, Enhertu® was approved in the US for a new indication (unresectable or metastatic HER2-low breast cancer).

August 22, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that the EMA has partially approved its phase III IND for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus® to treat multiple sclerosis.  The trial will assess biosimilarity of CT-P53 and Ocrevus®.  The clinical trial plan has been divided into two parts Part 1 (assessment of clinical design and product characteristics) and Part 2 (assessment of national and institution-level documents).  The trial cannot commence until Part 2 has been approved by the EMA.

In the same week on 24 August 2023, Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on more than 10 US formularies since its US launch on 17 April 2023.

Celltrion submitted its phase III IND plan for CT-P53 to the US FDA on 15 May 2023.

August 22, 2023

BMS announced that the European Commission has expanded the indication for its Opdivo® (nivolumab) as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.  Opdivo® is now the only PD-1 inhibitor that is indicated to treat stages IIB, IIC, III, and IV resected melanoma.

On 21 July 2023, the CHMP issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma.

August 21, 2023

The Japan Times has reported that a Ministry of Health, Labour and Welfare (MHLW) committee has recommended approval of Eisai/Biogen’s Leqembi® (lecanemab).  The article notes that the committee’s endorsement will be followed by approval by the Health Minister in the coming days.

On 6 July 2023, Leqembi® was approved by the FDA in the US to treat Alzheimer’s disease.  The product label notes it should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

August 18, 2023

Regeneron announced that the FDA approved its 8mg Eylea® (aflibercept) to treat Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).  The 8mg dose is the only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses.

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 18, 2023

Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders scheduled for 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz, which includes the planned spin-off effective date of 4 October 2023.

On 18 July 2023, Novartis’ board unanimously endorsed a Q4/23 Sandoz spin-off.

August 18, 2023

Regeneron announced that the FDA approved its Veopoz®(pozelimab-bbfg) to treat adult and pediatric patients over one year old with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.  CHAPLE is an extremely rare, life-threatening hereditary immune disease driven by an overactivation of the complement system, and less than 10 people in the US have the disease.  Veopoz® is a fully human monoclonal antibody designed to block the activity of complement factor C5.

On the same date, 18 August 2023, Regeneron announced that its 8mg Eylea® (aflibercept) was approved by the FDA to treat wAMD, DME and DR.

August 18, 2023

Samsung Bioepis filed an IPR petition against Regeneron’s US10,464,992 relating to formulations of aflibercept.  Samsung Bioepis has sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

Samsung Bioepis has previously filed petitions against Regeneron’s method of treatment patent US11,253,572 in April 2023 and US10,888,601 in April 2023, with a third IPR previously filed against a third method of treatment patent US10,130,681 in January 2023.

August 17, 2023

Celltrion Group revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that Celltrion, Inc. and Celltrion Health Co., Ltd will merge as part of the initial phase of its merger plan.  Following this stage, the company will proceed with the second phase: a merger of Celltrion and Celltrion Pharm, Inc.  The company said the merger is expected to generate increased revenue through cost reduction and enhancement of cost competitiveness.  The company aims to reach 3.5 trillion KRW revenue and 1.6 trillion KRW EBITDA by 2024 and 12 trillion KRW revenue by 2030.

On 26 July 2023, Celltrion has applied to the Korean Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea.

August 15, 2023

The British Generics and Biosimilars Associations (BGMA) has released a report finding that the NHS is projected to lose out on approximately £100M in savings per year by 2028 due to reduced biosimilar competition on the 85 biologics which are due to lose patent exclusivity in the next five years.

The figures were calculated by reference to the UK’s voluntary scheme for branded medicines pricing and access (VPAS) scheme, an agreement between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI).  VPAS sets a 2% per annum cap on the total allowed sales value of branded medicines to the NHS, and sales above that cap are repaid to DHSC through a rebate system.  Biosimilars also fall under this scheme.

Currently members of VPAS currently pay back 26.5% of their medicine sales, which is calculated so that the NHS’ net branded medicines sales increase only to that 2% rate per year.

The BGMA report states that the rising VPAS rate is threatening the launch of new biosimilars, as many manufacturers are not able to absorb the cost of competition as well as the VPAS rebate, ultimately leading to companies prioritising other markets.  The research shows that if on average one company is deterred from entering a biosimilar market where molecule exclusivity has been lost between 2023 and 2028,  the NHS is projected to lose out on around £100M in savings per year by 2028. If two entrants were lost, the figure increases to £250M.

VPAS is in place until 31 December 2023, and negotiations for the next five years are ongoing.  The proposed review of the 2023 scheme to control the cost of branded health service medicines consultation will run until 10 October 2023, and responses can be submitted at the DHSC website.

August 15, 2023

Sandoz published the results from MYLIGHT Ph III trials of its biosimilar aflibercept in patients with wet macular degeneration.  Sandoz reported that the study met its primary efficacy endpoint and showed no clinically meaningful differences to Regeneron’s Eylea®.  Sandoz commenced the MYLIGHT trials in May 2021 and expects to file for regulatory approval for its biosimilar aflibercept in the EU and US in the coming months.

On 18 August 2023, Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders on 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz.

August 15, 2023

Gilead and Tentarix Biotherapeutics announced have entered three multi-year agreements to leverage Tentarix’s Tentacles® platform to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.  Gilead said that the collaboration may provide access to next-generation, multi-specific biologics.  Tentarix will receive $66M in upfront payments and an equity investment from Gilead, whilst Gilead can acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for $80M each.

On 7 August 2023 Gingko Bioworks and Merck announced a US$490M collaboration to improve biologic manufacturing.

August 12, 2023

According to the Business Standard Biocon Biologics’ CEO has confirmed the transition of the North American part of Viatris’ global biosimilars business to Biocon Biologics will complete by the end of this quarter, less than a year after the companies signed a $3.34B acquisition of Viatris’ biosimilars business on 29 November 2022.  Biocon Biologics and Viatris have had a two-year transition services agreement in place following finalisation of the acquisition in November last year.  Biocon Biologics will also consider an IPO once Viatris is integrated.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.

August 11, 2023

Zumutor Biologics announced that FDA has granted its Investigational New Drug (IND) application for ZM008 (IgG1 monoclonal antibody) to initiate a phase I clinical study for the treatment of multiple solid cancers. The FDA approved the use of a staggered parallel clinical design for the combination of ZM008 and pembrolizumab which could benefit a wider range of patients whose immune response could be boosted with ZM008.

August 10, 2023

Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary injunction order made by the Munich District Court on 4 August 2023.  The preliminary injunction prevents Amgen from supplying Bekemv®, its biosimilar to Alexion’s Soliris® (eculizumab), in Germany unless certain conditions are met, including a requirement that Amgen customers, including hospitals, agree not to use Bekemv® off-label.

On 19 April 2023, the EMA approved Bekemv® for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) (after the CHMP provided its positive opinion on 23 February 2023).  Alexion successfully applied to the Munich Regional Court for a preliminary injunction in May 2023, which was upheld by the 4 August 2023 District Court ruling.

The ODE rights expired in June 2019 for PNH.   However Alexion argued that there was a real risk that the biosimilar would be used off-label to treat other conditions over which Alexion still has exclusive rights.  The District Court noted that by sending letters of recommendation to medical practitioners, Amgen contributed to the risk of Bekemv®’s off-label use.

Alexion has also sued Samsung Bioepis in Germany over its eculizumab biosimilar Epysqli®, approved by the EMA on 30 May 2023, with a preliminary injunction hearing scheduled for 16 August 2023.

August 10, 2023

On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements Under BsUFA III’ seeking comment and suggestions by 10 October 2023.

The guidance provides recommendations for applicants and FDA review staff on six classification categories for original and resubmitted supplements to approved applications. The commitment letter associated with the Biosimilar User Fee Amendments of 2022 sets out these supplement classification categories and their associated review performance goals. The guidance intends to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

August 10, 2023

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing intervals (including intervals greater than 12 weeks) and that the safety of aflibercept 8mg remained consistent with the known safety profile of Eylea®.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 10, 2023

The UPC has appointed 21 new technically qualified judges (TQJs) across various areas, including chemistry and pharmaceutics, biotechnology, mechanical engineering, electricity and physics.  Following a selection process, the UPC Administrative Committee adopted the final list of recommended candidates on 2 June 2023.  Further appointments of TQJs are expected to take place later in 2023, with interviews to be scheduled in the upcoming weeks.

On 2 June 2023, Sanofi-Aventis filed revocation proceedings in UPC in relation to Amgen’s Repatha® (evolocumab), one of the earliest UPC revocation cases filed – only one day after the Court’s commencement.

August 9, 2023

The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging Janssen’s US patent 10,961,307 relating to Stelara® (ustekinumab).  The Board’s decision follows Samsung and Janssen’s joint motion, dated 3 August 2023, stating that parties have resolved the dispute and request termination.  The motion states that the parties have entered into  a confidential settlement to resolve all present disputes and to avoid any additional disputes regarding the patent.

Samsung filed the IPR on 21 June 2023, arguing all claims of the patent are invalid, citing (amongst other things) a Janssen clinical overview summary for a phase III clinical trial of ustekinumab.

Samsung also filed a notice of opposition to the grant of an Australian counterpart, AU application no 2019346134, on 12 July 2023.  Law firm Reddie & Grose filed a post-grant notice of opposition (presumed to be on behalf of an unnamed client) to the European counterpart, EP patent no 3883606, on 27 July 2023.

August 9, 2023

News is my Business reported that the Puerto Rico Economic Development Bank (BDE) has approved US$3.85M in funding for Biosimilar Sciences PR LL and Ocyon Bio PR Inc. to facilitate the purchase of specialised biotechnology equipment. This funding comes from the US Treasury’s State Small Business Credit Initiative and represents BDE’s first partnership with a private financial entity, working alongside the Jesús Obrero Credit Union.  Biosimilar and OcyonBio are developing a biosimilar to AbbVie’s Humira® (adalimumab).

On 14 March 2022 OcyonBio and Biosimilar Solutions announced an agreement to create a contract biosimilars development/manufacturing organisation.

August 8, 2023

Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent no 10,406,226. Celltrion filed the IPR in February 2023, and it had not yet been instituted by the PTAB.  All claims of the ‘226 patent relate to a method of making a VEGF antagonist fusion protein involving expressing the fusion protein in CHO, purifying the fusion proteins such that a defined percentage is not an aggregate.

The results of Celltrion’s Ph III trials of CT-P42 were reported on 3 April 2023.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.  On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

August 7, 2023

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  There were no proceedings on foot between the parties on foot in relation to FYB202 at the time of the settlement.

On 25 April 2023, Formycon announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 to Stelara®.   Formycon expects to file its BLA for FYB202 with the FDA later in 2023.

This settlement follows Johnson & Johnson’s previous settlement agreements with Amgen (for a licensed entry date no later than 1 January 2024), and with  Alvotech and Teva (for a licensed entry date for AVT04 in the US no later than 21 February 2025).

August 7, 2023

On 7 August 2023 Gingko Bioworks and Merck announced a collaboration to improve biologic manufacturing.  Gingko will “apply its expertise and capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterization and process optimization to improve” [Merck’s] “production efficiency and increase yield”.  Merck will pay Gingko up to US$490M under the deal, including research fees, milestone fees and license payments.

This is the second collaboration between the companies, which announced a biocatalysis project to improve Merck’s active pharmaceutical ingredient manufacturing in October 2022.

August 3, 2023

Teva’s CEO confirmed that it will still pursue launching its Alvotech developed adalimumab biosimilar of AbbVie’s Humira® (adalimumab) next year despite seven biosimilars launching in the US on 1 July 2023, and Amgen launching Amjevita® on 31 January 2023.  Teva’s CEO, Richard Francis noted that “it’s always going to be a challenging market but I do see it’s worth the effort for 2024.”

On 24 July 2023, Teva and Alvotech announced they agreed to expand their existing strategic partnership agreement for the US, which already included development of AVT02 (adalimumab).

August 2, 2023

Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, has quadrupled to $26.7M since the last quarter.  It also reported that its net revenue has risen 81% compared to the previous quarter.  Yumisry®, Coherus’s biosimilar to AbbVie’s Humira® (adalimumab) was launched in the US on 3 July.

August 1, 2023

Astellas announced that China’s National Medical Products Administration (NMPA) has accepted its Biologics License Application (BLA) for zolbetuximab as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.  The BLA was based on phase III clinical trials which evaluated zolbetuximab with a combination chemotherapy regimen that included capecitabine and oxaliplatin.

August 1, 2023

Samsung Bioepis and Organon announced the topline results for their interchangeability study for SB5 (Hadlima®), a biosimilar to AbbVie’s Humira® (adalimumab).  The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) was in patients with moderate to severe chronic plaque psoriasis.  The study found that efficacy profiles, safety profiles and immunogenicity were comparable between patients who received Hadlima® and those who received Humira®.

SB5 was first approved by the FDA on 24 July 2019; and was launched in the US on 1 July 2023 at a list price of $1038, an 85% discount compared to Humira®.

July 27, 2023

AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive.  Soliris® is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU.  The company also confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are currently ongoing or planned with various health authorities.

The approval follows the CHMP recommendation for approval of the new indication on 26 June 2023.

July 26, 2023

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-related macular degeneration and diabetic macular edema.

Celltrion announced the results of its Ph III trials of CT-P42 on 3 April 2023 which demonstrated equivalence and similarity to Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.

On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

July 25, 2023

STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar  to Genentech’s Lucentis® (Ximluci®) in North America.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

After receiving EU approval in November 2022, STADA and Xbrane intend to commercialise the product in the US.  On 22 June 2023, Xbrane announced the FDA has accepted a supplemental Biologics License Application (sBLA) for  (Ximluci®).

July 24, 2023

Teva and Alvotech announced they have agreed to expand their existing strategic partnership agreement for the US with subordinated convertible bonds to be issued to Teva for USD$40M.

The expansion to the existing strategic partnership relates to exclusive commercialisation in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech.  The existing partnership includes:  two US biosimilar candidates pending FDA approval:

  • AVT02 (adalimumab), an interchangeable high-concentration biosimilar to AbbVie’s Humira®; and
  • AVT04 (ustekinumab) biosimilar to Janssen’s Stelara®

The agreement also covers milestone payments and shared profits from the commercialization of the biosimilars. All other terms of the expansion remain confidential.

The partnership was entered into between Alvotech and Teva on 5 August 2020.  On 6 January 2023, the two companies announced that the FDA accepted for review their BLA for AVT04, and on 12 June 2023 they reached a settlement and license agreement with Johnson & Johnson for AVT04.

On 12 June 2023, Alvotech and Teva reached a settlement and licence agreement with J&J regarding AVT04 (ustekinumab), biosimilar to Janssen’s Stelara®.

July 22, 2023

A Sandoz/Bio-Thera comparability study has demonstrated similarity between BAT1706  (bevacizumab) and Genentech’s Avastin® (bevacizumab) in terms of all physicochemical and functional attributes.

BAT1706 is currently under regulatory review by the FDA (BLA accepted on 18 January 2021) and the EMA (MA submitted on 26 November 2020).  BAT1706 has already been approved in China and is being supplied as Pobevcy®.

July 21, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

  • Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.
  • Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®.  Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
  • BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration

To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.

During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.

July 21, 2023

BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for its tislelizumab product, co-developed with Novartis.  It is seeking approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy.

In 2021, BeiGene and Novartis announced a collaboration agreement to jointly develop tislelizumab in the US, Canada, Mexico, member countries of the European Union, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Novartis is responsible for regulatory submission and has the right to commercialise in these licensed countries following regulatory approval.

On 10 July 2023, BeiGene and Novartis ended their option for collaboration and licence agreement to commercialise ociperlimab. Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.

July 21, 2023

Bristol Myers Squibb announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Opdivo® (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with completely resected stage IIB or IIC melanoma. If the European Commission approves this recommendation, Opdivo® will become the sole PD-1 inhibitor indicated as an adjuvant treatment for patients in stages IIB, IIC, III, as well as stage IV resected melanoma.

On 30 May 2023, the FDA accepted Priority Review for BMS’s NDA for repotrectinib for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer

July 21, 2023

Merck announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).

If approved, Keytruda® would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU.

July 20, 2023

Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test.  Vanflyta® is the first and only FLT3 inhibitor approved by the FDA for FLT3-ITD positive AML for all three phases of treatment (induction, consolidation and maintenance) in patients without a transplant and newly diagnosed AML.  Daiichi confirmed that Vanflyta® will be available in the US in the coming weeks.

On 12 July 2023, AstraZeneca and Daiichi’s Enhertu® (trastuzumab deruxtan) was approved for a new indication (unresectable or metastatic HER2-low breast cancer).

July 20, 2023

Sandoz announced that it will invest US$90M to build a Biosimilar Technical Development Centre in Ljubljana, Slovenia by 2026.  The site will house an end-to-end drug substance and product development centre, becoming a ‘key location’ for Sandoz’s biosimilar product development.

This news comes only a few months after Sandoz signed an MOU to build a USD$400M biologics facility in Lendava, Slovenia in March 2023.

July 18, 2023

Novartis announced that its Board of Directors has unanimously endorsed the proposed separation of Sandoz from the Novartis Group, by way of a spin-off planned for Q4 of 2023.  Shareholders at Novartis will have the opportunity to vote on the proposed spin-off and share capital reduction at an Extraordinary General Meeting on 15 September 2023.  The spin-off aims to list Sandoz on the SIX Swiss Exchange, and completion is dependent on shareholder approval, meeting specific conditions, and obtaining necessary approvals for the listing of Sandoz shares.

This week on 20 July 2023, Sandoz announced it will build a US$90M Biosimilar Technical Development Centre in Slovenia, due for completion in 2026.

July 18, 2023

BeiGene announced that the FDA has completed a GMP inspection of its tislelizumab manufacturing facility.  Tislelizumab is a PD-1 antibody and potential treatment for oesophageal squamous cell carcinoma (ESSC), and is being commercialised with Novartis.  The Company confirmed that the BLA is moving forward, and it is seeking to gain approval in the EU to treat ESSC, and approval in China to treat hepatocellular carcinoma.

Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.

July 17, 2023

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab) OSIP refused the application as the ‘837 patent application was filed in Canada after the submissions.

Health Canada approved ulcerative colitis as an indication for Stelara® on 27 January 2020.

July 17, 2023

AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It was also approved to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season.  The companies confirmed Beyfortus® will be available before the 2023/2024 RSV season.  The FDA approval follows a unanimous vote on 8 June 2023 by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favourable benefit-risk profile of Beyfortus® based on the clinical development programme spanning three late-stage clinical trials.

July 14, 2023

Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of Intas, on 23 June, and the EMA accepted the MAA submission on 14 July. Intas will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. 

On 22 July 2021, Intas Pharma announced it had signed a commercialisation agreement with Meiji and Dong-A St, under which Intas receives exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia. 

July 13, 2023

Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions, Ltd in the District Court of Massachusetts in relation to Biogen’s BIIB800, (biosimilar tocilizumab).  Genentech alleges that Biogen’s product, manufactured in China by Bio-Thera, will infringe 20 US patents, including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype).  On 9 December 2022 Biogen announced that the FDA had accepted its aBLA for BIIB800. 

July 13, 2023

Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation. Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA.  

Sen. Lee previously introduced the bill on 17 November 2022. 

July 12, 2023

Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab), has been accepted for review by the FDA. This follows acceptance of its DRL_RI dossier for review by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).  Rituxan®/MabThera® is approved for rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. 

We reported on 20 January 2023 that Dr Reddy’s successfully completed clinical studies of DRL_RI for filing in the US, EU and other regions against Rituxan®.  DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr Reddy’s directly in other jurisdictions. 

July 12, 2023

Prime Therapeutics announced its 2023 recommendations for formularies that include AbbVie’s Humira® (adalimumab).  The pharmacy benefit manager will recommend coverage of the following adalimumab biosimilars to commercial clients: 

  • Amgen’s Amjevita® (low concentration) and Boehringer Ingelheim’s Cyltezo® (interchangeable low concentration); or 
  • Amgen’s Amjevita® (low concentration) and Samsung Bioepis/Organon’s Hadlima® (high and low concentration). 

Prime is also recommending coverage of Cyltezo® for Medicare Part D formularies.  On 10 July 2023, Cigna Health announced its preferred adalimumab biosimilars.  

July 12, 2023

AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC), has been approved in China as a monotherapy to treat patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.  The approval by China’s National Medical Products Administration is based on the results of the DESTINY-Breast04 Phase III trial 

Based on the same clinical trial, Enhertu® was approved in Japan for the above indication on 27 March 2023.  

July 12, 2023

The Searle Company Limited announced that it has entered into a license agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and license the biosimilar drugs in Pakistan. 

In March 2023, Mabwell announced that it had received Chinese marketing approval for Mailishu®, its denosumab biosimilar, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture. 

July 12, 2023

A study comparing the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between AVT04 (ustekinumab biosimilar) and Janssen’s Stelara® in patients with moderate-to-severe chronic plaque psoriasis (PsO) has been published.   The authors report that the study demonstrates the therapeutic equivalence between AVT04 and Stelara® in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

Alvotech announced clinical studies supporting biosimilarity and comparability of ATV04 and Stelara® on 17 March 2023, and the data was presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

July 11, 2023

Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.  This is the first biologic treatment for this indication approved in India.  

On 21 May 2023 Sanofi and Regeneron announced positive results from their phase III Dupixent® study in COPD patients with chronic obstructive pulmonary disease. 

July 11, 2023

Samsung Bioepis has released its second US Biosimilar Market Report.  The quarterly report has updated price details of all products with launched biosimilars including updated 2023 Q3 average sale price (ASP) trends and wholesale acquisition cost (WAC) trends. For adalimumab: 

  • Organon/Samsung Bioepis’ Hadlima® and Coherus’ Yusimry® have a low WAC: ~85% less than Humira®  
  • Celltrion’s Yuflyma®, Boehringer Ingelheim’s Cyltezo®, and Fresenius Kabi’s Idacio® have a high WAC, only -5~7% below Humira®  
  • Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Biocon Biologics’ Hulio® are offering two pricing options including both a low and a high WAC    

Samsung Bioepis launched its first US Biosimilars Market Report on 18 April 2023, predicting that biosimilars will save US$181B in five years in the US.  

July 10, 2023

Samsung Biologics announced in a regulatory filing with Korea Exchange that it has signed a 511B (US$390M) contract with Novartis to manufacture its products in Korea from 1 January 2023 through to the end of 2028. The exact products which will be produced at the plant have not been revealed.  

The deal was announced on 7 June last year, when Samsung Biologics and Novartis signed a letter of intent for the deal. It was originally worth ₩100B (US$81M), however the companies have increased the investment by ₩411B.  

On 4 July 2023, Samsung Biologics announced two manufacturing deals with Pfizer worth US$897M.  

July 10, 2023

BeiGene announced in an SEC filing that it and Novartis have entered into a mutual termination and release agreement, terminating their agreement (announced on 19 December 2021) under which BeiGene granted Novartis an exclusive time-based option to receive an exclusive licence to develop, manufacture and commercialise ociperlimab.  BeiGene will continue enrolment in the phase III AdvanTIG 302 trial of ociperlimab in combination with BeiGene’s PD-1 inhibitor tislelizumab for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC), whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations.  

Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications tislelizumab.  

July 10, 2023

Cigna Healthcare, a pharmacy manager, announced it will prefer adalimumab biosimilars Boehringer Ingelheim’s Cyltezo®, Sandoz’s unbranded adalimumab-adaz, and Sandoz’s Hyrimoz high-concentration formulation alongside the originator product, Abbvie’s Humira® on its national preferred, standard, performance, and legacy commercial formularies.  Organon/Samsung Bioepis’ Hadlima®, in both high- and low-concentration formulations, will be preferred alongside Humira® on its value, advantage, and total savings formularies.  The announcement will be effective from 1 September 2023.   

In the first week of July 2023, seven biosimilars to AbbVie’s Humira® were made commercially available in the US. 

July 7, 2023

Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license agreement with the USA-based BioFactura Inc, to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara® (ustekinumab).  Ustekinumab is a recombinant monoclonal antibody for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Under the terms of the agreement, CuraTeQ has exclusive license rights to commercialise BFI-751 in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ as well as in certain other markets, and the global manufacturing rights.  The product will be produced at CuraTeQ facilities in Hyderabad, India.  BioFactura has plans to begin a global Phase 3 trial of the product.  CuraTeQ intends to file the product in India and ‘emerging markets’ as early as 2024 and in the regulated markets beginning in 2026.

July 6, 2023

Biogen Canada announced that Quebec will reimburse patients receiving BYOOVIZ® (ranibizumab), biosimilar to Genentech’s Lucentis®, for certain retinal conditions such as age-related macular degeneration (AMD) in the presence of choroidal neovascularization, and visual deficiency caused by diabetic macular edema (DME).

BYOOVIZ® is the first biosimilar approved in Canada (on 2 March 2023) to treat neovascular (wet) AMD and DME.

July 6, 2023

Biogen and Eisai announced that the FDA has approved the supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb) to treat Alzheimer’s disease (AD).  On 9 June 2023, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of the use of LEQEMBI® for AD.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

July 5, 2023

Biocon Biologics announced it has completed the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.  This signifies completion of the first stage of implementation of the Biocon buy out, wherein Viatris’ biosimilar operations were fully transitioned to Biocon.

The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.  Biocon announced that Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

July 4, 2023

A Hisun phase I study has demonstrated pharmacokinetic similarity and bioequivalence between HS628, a proposed tocilizumab biosimilar to Genentech’s Actemra®.  The safety and immunogenicity profiles of HS628 were also found to be similar to the reference product in healthy Chinese male subjects.  Actemra® is approved in the US for the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis patients.  The study also notes that a phase III clinical trial is currently underway to compare the efficacy and safety of HS628 and Actemra® in patients with moderate to severe RA.

On 5 June 2023, Dr Reddy’s announced a successful phase I study of its biosimilar to Actemra®.

July 4, 2023

Aurobindo Pharma announced that CuraTeQ Biologics’ BP02 showed equivalence to Genentech’s Herceptin® in its phase III clinical trial.  The study’s results indicated that BP02 has clinical response equivalence (pharmacokinetics and immunogenicity) and comparable safety profiles to the originator product.

On 26 June 2023, CuraTeQ Biologics withdrew its EMA MA applications for biosimilars ZEFYLTI® (filgrastim) and DYRUPEG® (pegfilgrastim) after receiving guidance from the EMA.

July 4, 2023

Samsung Biologics announced it has reached two agreements with Pfizer to manufacture its biosimilar products for oncology, inflammation and immunotherapy until 2029 in new South Korean Plant 4.

These announcements include a $704M contract and an additional $193M agreement (a follow-up to a $183M manufacturing deal previously announced on 2 March 2023).

July 1, 2023

Organon and Samsung Bioepis announced that Hadlima®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in the US.  Hadlima® is available at a list price of $1,038, an 85% discount in comparison to the list price of Humira®.

On 1 July 2023, the following biosimilar entities are licensed to launch: Alvotech, Celltrion, Boehringer Ingelheim, Coherus before Fresenius Kabi  in July (on an unspecified date), Mylan/Viatris on 31 July 2023, Sandoz on 30 September  2023,  Momenta and Pfizer on 20 November 2023.

July 1, 2023

Seven biosimilars to AbbVie’s Humira® (adalimumab): Coherus Biosciences’ Yusimry®, Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® are now commercially available in the US.

Each became authorised for supply in the US in July 2023 following their respective settlements with AbbVie. Samsung Bioepis settled with AbbVie on 5 April 2018, Viatris settled on 17 July 2018 (Biocon Biologics acquired Viatris’ global biosimilars business in November 2022), Sandoz settled on 11 October 2018, Fresenius settled on 18 October 2018, Boehringer settled on 14 May 2019, and Coherus settled on 27 November 2019, and Celltrion obtained a licence from AbbVie on 27 April 2022.

AbbVie entered into other deals with biosimilar entrants enabling US market entry, including: Alvotech (market entry on 1 July 2023, which has been delayed by a recent CRL from the FDA), Momenta (market entry on 20 November 2023), and Pfizer (market entry on 20 November 2023).

June 30, 2023

The Korea Biomedical Review reported that Celltrion has filed an NDA with the FDA for CT-P42 (aflibercept), biosimilar to Regeneron’s Eylea®.  Based on its phase III trials which demonstrated equivalence and similarity to Eylea®, Celltrion is seeking approval for all adult indications (including wet age-related macular degeneration and diabetic macular edema).  Celltrion will seek marketing authorisation for CT-P42 in key markets including Europe.

June 30, 2023

Kashiv Biosciences has completed a Phase I study comparing ADL-018, its omalizumab biosimilar, to Xolair® as marketed in the US by Genentech and in Europe by Novartis.  The study was a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study following single subcutaneous dosing in 306 healthy, adult subjects.

No results have been posted.

Amneal Pharmaceuticals and Kashiv Bioscience developed Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.

June 29, 2023

The US District Court of Delaware has denied Biogen’s motion for preliminary injunction in its proceedings against Sandoz which were commenced in September 2022 regarding Sandoz’s natalizumab biosimilar.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.   Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents. Oral argument was heard on 17 May 2023.  The Court held that Biogen failed to demonstrate that it would suffer irreparable harm in the absence of an injunction and that it would likely succeed on the merits.  Interestingly, the Court confirmed in a footnote of the orders that it will ‘try its best to schedule a trial before April 2025’.

June 29, 2023

Express Pharma reported that Enzene Biosciences announced its launch of bevacizumab, biosimilar to Genentech’s Avastin®, in India to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

This news comes after Lupin and Enzene announced on 30 May 2023 a strategic collaboration to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’s Erbitux®.

June 29, 2023

Formycon and Klinge Biopharma announced that its BLA for FYB203 (biosimilar to Regeneron’s Eylea® aflibercept) has been submitted to the FDA. A response from the FDA is expected by the end of August 2023.  FYB203 is being developed by Formycon, and will be commercialised by Klinge Biopharma.

June 28, 2023

Alvotech provided an update about its high concentration adalimumab (AVT02) application in the US.  Alvotech has announced that the FDA issued a complete response letter (CRL) for its second BLA for AVT02 (high-concentration adalimumab, biosimilar to AbbVie’s Humira®, with interchangeability designation).   The CRL highlighted certain deficiencies found during the FDA’s reinspection of Alvotech’s facility in Reykjavik, Iceland must be resolved before the AVT02 application can be approved. Alvotech will now submit a new BLA for AVT02, with data supporting its interchangeability designation. Alvotech is exploring options to raise additional capital “due to the expected delay in the potential approval of AVT02 in the US”.

On 13 April 2023, Alvotech announced that had received and responded to the first CRL from the FDA regarding AVT02.   From 1 July 2023, Alvotech is licensed to supply AVT02 in the US from 01 July 2023 in accordance with its licence agreement with AbbVie.

June 28, 2023

Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana.  On 27 June 2023, Regeneron announced that that the FDA had issued a CRL in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 27, 2023

Regeneron announced that the FDA has issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.  Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG as a higher dose formulation of aflibercept (compared to the currently approved 2mg Eylea®) with the aim of extending treatment intervals.

Regeneron reported that the CRL was issued in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.  Regeneron reported that it will work with the FDA and the third-party filler to obtain approval as soon as possible.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 26, 2023

UCB announced that its Biologics License Application (BLA) for bimekizumab to treat moderate to severe plaque psoriasis remains under review with the FDA.  The FDA acceptance was expected in Q2, 2023, however it is not anticipated that the FDA will do so in Q3 2023.  Bimekizumab is an IL-17A and IL-17F inhibitor, is currently approved for moderate to severe psoriasis by 10 regulatory authorities and in 39 countries worldwide.

In June 2023, bimekizumab was approved for two additional indications in Europe – the treatment of adults with active psoriatic arthritis, and for the treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.

June 26, 2023

Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The withdrawal was made after guidance was received from EMA, which advised the Company it will not obtain EU-GMP certification of its biosimilars manufacturing facility within the current Day 180 clock stop period, which would not be extended.  CuraTeQ confirmed it will work with the EMA to re-submit the applications as soon as possible.

On 11 January 2022, Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe.

June 26, 2023

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the MA for Astra Zeneca’s Soliris® (eculizumab) be expanded to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor antibody-positive.  AZ confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are pending or planned with multiple health authorities.

On 13 June 2023 the Chinese NMPA approved Soliris® for treatment of gMG in adults who are anti-acetylcholine receptor antibody-positive.

June 24, 2023

Ocuphire announced its phase II clinical trial poster was presented at the 83rd Scientific Sessions of the American Diabetes Association, titled “Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment—Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy”.  APX3330 is a first-in-class, small molecule oral drug, and is seeking to provide an alternative to intravitreal injection treatments.  The clinical trial demonstrated that APS3330 reduced clinically meaningful progression of diabetic retinopathy (DR), as measured by the DR severity scale (DRSS).

Ocuphire is meeting with the FDA for its End of Phase 2 meeting to confirm the Phase 3 study design.

June 23, 2023

Boehringer Ingelheim announced that Optum Rx, pharmacy benefit manager, will place Cyltezo® (adalimumab-adbm), the FDA-approved Interchangeable biosimilar to AbbVie’s Humira® on its commercial formulary as a preferred brand.  Optum Rx covers more than 66 million members in the US.

Optum Rx will also supply two other adalimumab biosimilars, Sandoz’s Hymiroz® and Amgen’s Amjevita®

Cyltezo® became authorised for supply in the US on 1 July 2023 following the Boehringer and AbbVie settlement  of their patent dispute on 14 May 2019.

June 22, 2023

ASLAN Pharmaceuticals announced that it entered an exclusive licence with Zenyaku Kogyo to develop and commercialise eblasakimab (a first-in-class monoclonal antibody) to treat atopic dermatitis in Japan.  ASLAN will receive an upfront payment of $12M from Zenyaku and is eligible for an extra $3M if it meets specific conditions relating to phase IIb trial data and delivery of the clinical study report.  ASLAN can potentially earn up to $29.5M in development milestones and up to $94M in commercial milestones.

Zenyaku will conduct a phase I study of eblasakimab in Japan during the first half of 2024 and will make royalty payments to ASLAN based on net sales of eblasakimab.  ASLAN retains an option to reacquire the rights to eblasakimab in Japan at any time in the future.

June 21, 2023

Samsung Bioepis has filed an IPR in the US against Alexion’s Soliris® (eculizumab) patent 10,703,809 (’809 patent) advocating that all claims of the ‘809 patent are obvious in light of the prior art (including patent applications, a granted patent, manuscripts and a journal article).

On the same day, Samsung Bioepis also filed an IPR against Janssen’s Stelara® (ustekinumab) patent no. 10,961,307 (‘307 patent), addressed here

June 21, 2023

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a Janssen clinical overview summary for a phase III clinical trial of ustekinumab (NCT-236).   All claims (1-34) are allegedly obvious in light of NCT-236 combined with a journal article and the Stelara® Prescribing Information.

On the same day, Samsung Bioepis filed an IPR against Alexion’s US patent no. 10,703,809 (’809 patent) relating to Soliris® (eculizumab).

On 12 June 2023 Alvotech and Teva announced they reached a settlement and licence agreement with J&J for AVT04 (Alvotech’s biosimilar to Stelara®) providing a licensed US launch date of no later than 21 February 2025, and on 22 May 2023 Amgen settled its Stelara® patent invalidity suit with Janssen in the US with a licensed US launch date of no later than 1 January 2025.

June 21, 2023

Xbrane Biopharma announced the FDA has accepted a supplemental Biologics License Application (sBLA) for its biosimilar to Genentech’s Lucentis® (ranibizumab) to treat serious eye diseases such as wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.  The Biosimilar User Fee Amendment goal date is 21 April 2024.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

On 25 April 2023, STADA and Xbrane together announced the supply of Ximluci® (ranibizumab) on the NHS in England.

June 20, 2023

LOTTE Biologics announced it has signed a memorandum of understanding with LOTTE Corporation, Incheon Metropolitan City and the Incheon Free Economic Zone to establish biologics production facilities in the area.  LOTTE Biologics plans to construct three mega plants by 2030, that can produce 360,000L of biologic therapeutics.

On 8 June 2023, Samsung Biologics and Pfizer announced a US$411M collaboration to manufacture biosimilars in Korea.

June 16, 2023

BusinessWire reports that Bio-Thera Solutions and Biomm SA have reached a licensing and supply agreement for BAT2206 (ustekinumab biosimilar).  Under the agreement, Biomm will have exclusive rights to distribute and market the product in Brazil.

We previously reported that Bio-Thera has previously entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

June 16, 2023

Merck announced that it has acquired Prometheus Biosciences, Inc. which is now a wholly-owned subsidiary of Merck.  Prometheus’ leading candidate product PRA-023 (now known as MK-7240), is a humanized monoclonal antibody being developed to treat immune-mediated diseases such as autoimmune disease, ulcerative colitis and Crohn’s disease.

This news comes shortly after the FDA accepted sBLA for Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy for advanced or unresectable biliary tract cancer on 8 June 2023.

June 15, 2023

The Economic Times in India reported that Glenmark provided a drastic price drop in India for Trumab® (trastuzumab), biosimilar to Genentech’s Herceptin®.  Glenmark reduced the cost of its 440mg vial from ₹54,000 down over 70% to ₹15,749 in a market supplying the medicine for between Rs 40,000 and Rs 50,000 per vial.