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Home / News / BioBlast®

 

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

July 7, 2024

On 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  The SEC has also conditionally approved Zydus’ biosimilar for all other approved indications of BMS’s Opdivo® (nivolumab) in India, subject to Zydus conducting a Phase IV study for those indications. 

In September 2020, NeuClone Pharmaceuticals disclosed that it was working on a nivolumab biosimilar, with the product being developed in partnership with the Serum Institute of India. 

July 5, 2024

On 5 July 2024, Roche announced that the FDA has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6 mg) for nAMD, diabetic macular oedema and macular oedema following retinal vein occlusion.  Roche reports that the product is the first PFS with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness. 

Vabysmo® was first approved in the US in January 2022 in a vial format and is available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion. 

July 4, 2024

On 4 July 2024, Celltrion announced that it received final approval from the European Commission for an additional dosing regimen and dose increase for Remsima SC® (infliximab). The approval comes almost a month after the CHMP issued a positive opinion for the new dosing. 

As previously reported, the new dosing regimen involves three additional IV doses for CD and UC patients with Remsima SC administered from week 10.  The dose increase provides for as-needed escalation to 240 mg of Remsima SC® maintenance therapy in CD patients who have experienced decreased efficacy following 120mg of Remsima SC®. 

Remsima SC® has been approved in Europe since 2013.  In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US. 

July 3, 2024

Novo Nordisk’s weekly injection insulin Icodec is reported as nearing approval in India following a 19 June 2024 recommendation by the Subject Expert Committee under India’s drug controller to permit the import and sale of the drug. 
 
This news follows the approval of Novo Nordisk’s Wegovy® in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity. The company also announced last month its plans for a $4.1 billion expansion of its US manufacturing capacity. 

July 3, 2024

On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.  This is the first approval of Dupixent for COPD anywhere in the world, and the sixth approved indication for the drug in the EU.   

Dupixent was recommended by the CHMP for COPD on 31 May 2024.  In February 2024, the FDA accepted Dupixent® for priority review for the same indication.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.

July 2, 2024

On 2 July 2024, Eli Lilly announced that the US FDA has approved its KisunlaTM (donanemab-azbt) for early symptomatic Alzheimer’s Disease (patients with mild cognitive impairment or mild dementia stage of disease).  Once-monthly Kisunla is the first amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.  This is reported to result in lower treatment costs and fewer infusions.  

  

The 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. 

July 2, 2024

Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical similarity in efficacy, safety, immunogenicity, and pharmacokinetics (PK) between AVT03 and Prolia®. Positive results from two additional PK studies comparing AVT03 with Prolia® and Xgeva® also showed equivalent safety and tolerability.  

Alvotech’s announcement states that it expects to file marketing applications for AVT03 in major global markets later in 2024. 

This comes after Alvotech’s announcement last month that it has expanded its current partnership with STADA to include AVT03 for EU, UK and Switzerland. 

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).

July 2, 2024

According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract extends until 31 December 2030 and is said to significantly boost Samsung Biologics’ annual order volume, reflecting a 40% increase over the previous year’s total orders.  

This follows Samsung Biologics’ contract manufacturing agreement with Kiniksa Pharmaceuticals last month and the announcement, on 7 February 2024 that Samsung Biologics has partnered with Lego Chem Biosciences to develop and manufacture ADCs. 

July 2, 2024

Fresenius Kabi has launched its subcutaneous formulation of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  This new formulation provides patients with primary immunodeficiency diseases a convenient alternative to intravenous administration. 

Both subcutaneous and intravenous forms of Tyenne were FDA approved on 5 March 2024. Fresenius launched the IV formulation of Tyenne in the US in April 2024.  Fresenius Kabi launched Tyenne in Europe as the first to market biosimilar in November 2023 in both IV and SC formulations. 

July 2, 2024

Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.  The resubmission aims to address approvability deficiencies identified in a previous Complete Response Letter (CRL), relating to findings during an inspection of its third-party contract manufacturing organisation. The CRL did not state concerns about the clinical data, safety, or labelling for cosibelimab. 

July 1, 2024

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).   
 
ADL018 was developed by Kashiv and is currently in a Phase III clinical trial, commenced in October 2023, in patients with chronic idiopathic/spontaneous urticariaKashiv completed a Phase I clinical trial for ADL018 on 30 June 2023. 
 
Amneal and Kashiv have previously partnered including in relation to Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022. 
 
In October 2023, Alvotech announced that it had entered an exclusive licensing agreement with Kashiv for ADL018 (AVT23) in the EU, UK, Australia, Canada, and New Zealand.

July 1, 2024

On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept)According to the press release, Altos Biologics expects to receive approval by 2025 and intends to negotiate licence agreements with potential distributors worldwide. 
 
Altos Biologics completed enrolment in its Phase III trials of ALT-L9 in patients with nAMD in February 2023The trials reportedly demonstrated therapeutic equivalence between ALT-L9 and Eylea®.  
 
Biocon received marketing approval for its aflibercept biosimilar (Yesafili®) in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023.

July 1, 2024

On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. CHMP’s recommendation is a key step in the European Commission’s final approval process, with approval imminently anticipated.  
 
CHMP’s recommendation follows Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024. Celltrion is also seeking approval for Steqeyma in the United States, and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.

July 1, 2024

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®. 

Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered into in November 2023 resolving pending US litigation between the companies. 

Samsung Bioepis’ SB17 was approved in April 2024 in Europe (as Pyzchiva®) and Korea (as EpyztekTM).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

A number of ustekinumab biosimilars are currently approved in Europe, including Alvotech and STADA’s Uzpruvo® (January 2024). Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.

July 1, 2024

Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. 

In December 2019, Tanvex and Amgen settled US litigation brought by Amgen in relation to Tanvex’s filgrastim biosimilar. 

The first filgrastim biosimilars approved in Europe were Ratiograstim and Tevagrastim in 2009.  Soon after, Hospira’s filgrastim biosimilar was approved in Australia in 2010. Sandoz’s Zarxio was approved in the US in March 2015.  It is interesting to see new biosimilars still being approved over 20 years later.

July 1, 2024

AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer. 

July 1, 2024

New and expanded Pharmaceutical Benefits Scheme (PBS) listings are to be implemented in Australia for AstraZeneca/MSD’s Lynparza® (olaparib), expanded for use for patients with human epidermal growth factor receptor 2 negative (HER2-negative) high-risk early breast cancer with specific gene mutations, and AstraZeneca’s Saphnelo® (anifrolumab), listed for the first time to treat the severe systemic form of lupus erythematosus (SLE) in patients with high disease activity despite standard treatment. 

June 28, 2024

On 28 June 2024, the results of a switching study on Fresenius Kabi’s® (MSB11022 adalimumab biosimilar) were published in Current Medical Research and Opinion, following presentation at the 2024 European Congress of Rheumatology (EULAR) earlier in June.  The study demonstrated that switching patients with rheumatoid arthritis from AbbVie’s Humira® (adalimumab) to Idacio® produced comparable results in terms of efficacy, safety and immunogenicity.   

The first Humira® biosimilar (Amgen’s Amjevita®) was launched in the US on 31 January 2023, with multiple additional biosimilars entering the US market in July 2023.  In February 2024, Teva and Alvotech’s Simlandi® was FDA approved as the first interchangeable, high concentration, citrate free adalimumab biosimilar. Simlandi was launched in the US in May 2024. 

June 28, 2024

On 28 June 2024, Zydus and Dr Reddy’s announced that they have entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India.  Dr Reddy’s receives semi-exclusive rights under the agreement, while Zydus will receive upfront and subsequent milestone payments.  Zydus will market its pertuzumab biosimilar to Roche’s Perjeta® under the trade name Sigrima™, with Dr Reddy’s supplying Womab®. 

This comes after Medical Dialogues published on 27 June 2024 that New Delhi’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO), approved Zydus Life Sciences’ pertuzumab biosimilar for the additional indication of early breast cancer. CDSCO’s approval is conditional on Zydus conducting a Phase IV study of the drug for the new indication. 

Earlier this month, results of a study sponsored by Qilu Pharmaceuticals were published demonstrating comparable efficacy and safety of Qilu’s QL1209 to Perjeta® (pertuzumab) in neoadjuvant treatment of HER2-positive, ER/PR-negative, early or locally advanced breast cancer. 

June 28, 2024

Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab).  The studies demonstrated that HLX15 has similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US, EU, and CN sourced Darzalex®. 

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

June 28, 2024

Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion.  If approved, faricimab will be the first bispecific antibody treatment available in the EU for RVO.  A final decision of the European Commission is expected soon. 

Vabysmo has previously been approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.  It is approved in 95 countries for nAMD and diabetic macular oedema. 

June 28, 2024

On 28 June 2024, Formcyon and Klinge Biopharma GmbH announced that FDA has approved FYB203, biosimilar to Regeneron’s Eylea® (aflibercept) for nAMD, Diabetic Macular Edema, Diabetic Retinopathy and Macular Edema following Retinal Vein Occlusion.  Klinge, which holds the global commercialisation rights for Formycon’s FYB203, will commercialise the biosimilar in the US as AHZANTIVE® (aflibercept-mrbb). 

FYB203 is the third aflibercept biosimilar to be approved in the US, after Samsung Bioepis’ Opuviz and Biocon’s Yesafili® were both approved as biosimilars to Eylea® with interchangeability in May 2024. 

The US launch dates for the biosimilars remain uncertain due to ongoing BPCIA patent litigation brought by Regeneron against FormyconSamsung Bioepis and Biocon (amongst others) regarding aflibercept.  Preliminary injunctions were issued in relation to Formycon’s and Samsung Bioepis’ aflibercept biosimilars on 21 and 14 June 2024, respectively, while a permanent injunction was granted against Biocon on 11 June 2024.

June 28, 2024

On 28 June 2024, AbbVie announced its acquisition of Celsius Therapeutics, a privately owned biotech firm developing treatments for patients suffering from inflammatory diseases. This includes  CEL383, an anti-TREM1 antibody which has successfully completed a Phase 1 clinical trial for treating IBD. 

This news follows AbbVie’s announcement in January 2024 that it is investing US$223M in expanding its biologics manufacturing facility in Singapore. 

June 27, 2024

On 27 June 2024, Korea Biomedical Review reported that Samsung Bioepis intends to launch its ustekinumab biosimilar Epyztek™ in Korea in July 2024.  The product will be supplied at a 40% discount to J&J’s Stelara® (ustekinumab). 

Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab) was approved by the South Korean Ministry of Food and Drug Safety for all Stelara® indications earlier this month.  No launch date for Steqeyma has been announced to date. 

June 27, 2024

On 27 June 2024, Coherus BioSciences announced that it has agreed to divest its Yusimry™, biosimilar to AbbVie’s Humira (adalimumab), to Hong Kong King-Friend (HKF) for up-front all-cash consideration of USD $40M.  On the same day, Meitheal Pharmaceuticals, wholly owned subsidiary of HKF, announced it has received an exclusive US licence for the supply of Yusimry™ from HKF.  

Meitheal expects to receive US approval for the high concentration formulation of Yusimry™ in 2025.  

This divestment comes 12 months after a settlement between AbbVie and Coherus relating to AbbVie’s allegations of breach of contract relating to the Coherus settlement and licence agreement entered into in late 2019, under which Coherus received a royalty bearing non-exclusive licence to commercialise its biosimilar adalimumab Yusimry® from 1 July 2021. 

Yusimry was launched in the US in July 2023, together with Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® pursuant to their respective settlement agreements with AbbVie. 

June 27, 2024

At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  The recommendation is for moderately to severely active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis. 

This news follows approval of Steqeyma in South Korea earlier this month.  Celltrion is also seeking approval for Steqeyma in the US (FDA application submitted in June 2023) and Australia (TGA application submitted in April 2023). 

Ustekinumab biosimilars currently approved in Europe are Alvotech and STADA’s Uzpruvo® (January 2024) and Samsung Bioepis’ Pyzchiva® (April 2024).  Amgen’s Wezenla® received a positive CHMP recommendation in April 2024. 

June 27, 2024

On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission voluntarily includes new safety data following a Phase 3 trial extension period.

In December 2023, Harbour BioMed’s 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). 

June 26, 2024

Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity.   

The approval comes as the company plans a $4.1 billion expansion of its US manufacturing capacity. 

On 17 April 2024, Biocon announced the signing of an exclusive licensing and supply agreement to provide generic Ozempic® (semaglutide) in Brazil. Earlier in the month, on April 10 2024, Boston-based Ginkgo Bioworks announced an expansion of its partnership with Novo Nordisk aimed at enhancing the manufacturing processes for Novo Nordisk’s medications, particularly those targeting chronic diseases like diabetes and obesity.  Meanwhile, on 2 April 2024, Hangzhou Jiuyan Gene Engineering announced that its Chinese application for Jiyoutai™, a biosimilar to Novo Nordisk’s Ozempic® (semaglutide) for type 2 diabetes, had been accepted.  

June 26, 2024

On 25 June 2024, Simcere Zaiming announced the approval of Enlituo® (cetuximab beta) in the PRC for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). The drug was developed in collaboration with Mabpharm Limited with the cetuximab molecule designed to avoid glycosylation modifications that may lead to hypersensitivity.

June 25, 2024

On 25 June 2024, Novo Nordisk announced its plan to significantly boost its investment in manufacturing in 2024, allocating USD $6.8 billion towards production.  This is up from USD $3.9 billion the previous year.  

The plan includes a USD $4.1 billion investment to build a second manufacturing facility in Clayton, North Carolina, expanding its capacity to produce injectable treatments for obesity and chronic diseases. The new facility will add 1.4 million square feet of production space and create 1,000 new jobs.  

This news follows Ginkgo Bioworks’ announcement on 10 April 2024 of an expansion of its partnership with global healthcare leader, Novo Nordisk.  

June 25, 2024

Business Korea reports that Samsung Biologics has entered a contract manufacturing agreement with US based Kiniksa Pharmaceuticals. The deal, valued at approximately USD $156m (211b won) covers the period 21 June 2024 to 31 December 2031. 

This follows the announcement on 7 February 2024 that Samsung Biologics has partnered with Lego Chem Biosciences to develop and manufacture ADCs. 

Earlier this year, Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products.  

June 25, 2024

On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria.  This is the first omalizumab biosimilar approved in Korea. 

Omlyclo® was also the first omalizumab biosimilar approved in Europe for allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.  Celltrion is currently defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®. 

Celltrion submitted an aBLA in the US for its omalizumab biosimilar (CT-P39) in March 2024 and in Canada in December 2023.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

June 25, 2024

On 25 June 2024, Evotec announced that its subsidiary, Just – Evotec Biologics, Inc., has been selected by the U.S. Department of Defense to develop an accelerated monoclonal antibody development and manufacturing solution as part of the department’s Manufacturing Optimization Program. The multi-year program award, valued at up to USD$39 million, aims to bolster the U.S. Government’s rapid response capability with biologics medical countermeasures. 

Just-Evotec partnered with Sandoz in May of 2023 to develop and manufacture multiple biosimilar medicines (with an option for expansion).  

June 24, 2024

On 24 June 2024, Biogen announced its IV tocilizumab, TOFIDENCE™, biosimilar to Roche’s ROACTEMRA®, has been approved by EC.  Tofidence is authorised by the EC for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.   

This is the second tocilizumab biosimilar approved in the EU following the approval of Fresenius Kabi’s tocilizumab biosimilar, Tyenne® for the treatment of rheumatoid arthritis in September 2023. 

This approval follows the positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for Tofidence in April 2024, and the FDA approval of Biogen’s Tofidence in September 2023.  

June 24, 2024

On 24 June 2024, Teva Pharmaceuticals announced the US launch of its authorised generic liraglutide injection (1.8 mg) for type 2 diabetes.  Originator Novo Nordisk supplies liraglutide as Victoza®, and Teva’s authorised generic Victoza is the first generic GLP-1 treatment available in the US 

This news follows Adalvo’s announcement on 13 June 2024 that its liraglutide pre-filled pen was approved in the EU, making it the first EU approved generic liraglutide. 

June 24, 2024

On 24 June 2024, Biocon Biologics announced that it received approval from the European Medicines Agency to manufacture biosimilar bevacizumab from its  multi-product mAbs facility at Bengaluru. 

Biocon received EC authorisation for its Abevmy® (biosimilar bevacizumab) in April 2021. 

June 21, 2024

On 21 June 2025, Argenx announced that the FDA approved a new indication of its VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for chronic inflammatory demyelinating polyneuropathy (CIDP).  

VYVGART Hytrulo is approved for CIDP, administered as a subcutaneous injection once weekly lasting 30 to 90 seconds. It is notable as the only neonatal Fc receptor (FcRn) blocker approved for treating CIDP. 

June 21, 2024

Results of phase 3 pertuzumab studies comparing Qilu’s QL1209 with Roche’s Perjeta® with trastuzumab and docetaxel were published in the British Journal of Cancer on 21 June 2024.  

The studies demonstrated that QL1209 is equivalent to Perjeta® in safety and efficacy for patients with HER2-positive, ER/PR-negative, early or locally advanced breast cancer. 

QL1209 is reportedly the first pertuzumab biosimilar produced and submitted for approval in China.  

June 21, 2024

On 14 and 21 June, respectively, the United States District Court for the Northern District of West Virginia granted Regeneron’s motions for preliminary injunctions against Samsung Bioepis and Formcyon (unpublished to date), preventing them from launching their US biosimilars to Regeneron’s Eylea® (aflibercept).  The orders were made in the BPCIA litigation brought by Regeneron against each of Samsung Bioepis, Formycon, Biocon, Celltrion and Amgen. The order against Samsung Bioepis was published on 24 June 2024, while that against Formycon  remains under seal.   

The preliminary injunction orders are based on the Court’s determination that Samsung Bioepis (Opuviz FDA-approved in May 2024) and Formycon (aBLA for FYB203 accepted by FDA in August 2023) infringed Regeneron’s US patent 11,084,864 (ophthalmic formulations of a VEGF antagonist).   

Both Samsung Bioepis and Formycon lodged appeals from the preliminary injunction orders (on 14 June 2024 and 25 June 2024, respectively).  On 19 June 2024, Samsung Bioepis also filed an Emergency Motion to stay the preliminary injunction pending the appeal. 

This comes after the Court granted Regeneron’s permanent injunction motion on 11 June 2024 (order published on 21 June 2024), preventing Biocon from launching its Yesafili (FDA approved in May 2024) in the US without a licence.   Biocon filed a Notice of Appeal on 21 June 2024.  Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023) and Amgen (aBLA for ABP 938 accepted by FDA in October 2023). 

June 20, 2024

On 20 June 2024, Korea Biomedical Review reported that Celltrion has successfully applied to be the exclusive supplier of Remsima® (biosimilar to Janssen’s Remicade® (infliximab)), Herzuma® (biosimilar to Roche’s Herceptin® (trastuzumab)) and Vegzelma® (biosimilar to Genentech’s Avastin (bevacizumab)) to France’s largest pharmaceutical procurement Group (Union des Hopitaux pour les Achats (UniHA)) The supply arrangement will continue until June 2027. 

Celltrion has also secured a 4 year-contract to supply Herzuma and Vegzelma to the Bretagne regional public hospital network in France.  

This follows Celltrion’s recent tender successes regarding Remsima® and Herzuma® in Peru (May 2024) and Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).  In February 2024, Celltrion also secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar). 

June 19, 2024

On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows Biocon to commercialize Bmab 1200, subject to regulatory approval, in the U.S. by no later than 22 February 2025. More recently, industry media has reported that Biocon’s Bmab 1200 is currently in Phase III for the treatment of Crohn’s Disease. 

June 18, 2024

On 18 June 2025, AbbVie announced that the FDA approved its Skyrizi® (Risankizumab) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease. 

AbbVie’s Skyrizi® (risankizumab) was approved in November 2023 by the Korean Ministry of Food and Drug Safety (MFDS) to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies. 

June 18, 2024

On 18 June 2024, Alvotech announced that it has entered into an agreement with Advanz Pharma in relation to the commercialisation in Europe of Alvotech’s AVTO6 and AVT29, biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively.  Advanz Pharma’s commercialisation rights are exclusive throughout Europe, except in Germany and France, where they are semi-exclusive.   

Under the agreement, Advanz Pharma is required to make an upfront payment to Alvotech, with further payments due on certain development and commercialisation milestones. 

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, biosimilar to Novartis’ Xolair (omalizumab).  That agreement covered Europe, UK, Switzerland, Canada, Australia and New Zealand. 

June 18, 2024

Samsung Biologics has renegotiated its manufacturing agreement with Baxter Healthcare, increasing Baxter’s payments to Samsung to over US$223 million through the end of 2034, up from an initial US$15m. The specifics of the products Samsung will manufacture for Baxter remain undisclosed. 

This follows Samsung Biologic’s announcement on 7 February 2024 that it had partnered with Lego Chem Biosciences to develop and manufacture ADCs. 

June 17, 2024

As previously reported, on 6 May 2024, the United States District Court for the District of Delaware refused to grant Alexion preliminary injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating paroxysmal nocturnal hemoglobinuria (PNH) (US 10590189) and atypical haemolytic uremic syndrome (aHUS) (US 9447176) with eculizumab.  

On 14 May 2024, Alexion filed a Notice of Appeal from the Court’s decision denying the preliminary injunction and, on 17 May 2024, Alexion sought an emergency injunction pending the appeal.  On 17 June 2024, the Court refused Alexion’s motion for an emergency injunction, finding that there was a substantial question of validity in relation to the patents. 

The injunction applications are part of the BPCIA litigation commenced by Alexion on 3 January 2024 alleging infringement of 6 patents relating to Samsung Bioepis’ aBLA for SB12, its biosimilar to Alexion’s Soliris® (eculizumab).  The litigation is ongoing. 

SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024. 

June 17, 2024

On 17 June 2024, Merck (known as MSD outside the US and Canada) announced that the US FDA has approved its anti-PD-1 therapy, Keytruda® (pembrolizumab) in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial carcinoma. 

This is the first FDA-approved anti-PD-1 therapy for this indication and the third FDA-approved indication for Keytruda® in endometrial carcinoma.  Keytruda received FDA-approval in March 2022 as a single agent for advanced endometrial carcinoma that is MSI-H or dMMR, and in combination with lenvatinib for such cancer that is not MSI-H or dMMR. 

June 14, 2024

On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for nAMD and DME. 

High dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME), Japan (January 2024 – nAMD and DME) and Korea (April 2024 – nAMD and DME). 

June 14, 2024

On 14 June 2024, the Patent Trial and Appeal Board (PTAB) issued a final decision[Marketing to link to PDF document] in Samsung Bioepis’ Inter Partes Review Proceeding (IPR2023-00442) relating to Regeneron’s US Patent No. 10,130,681 (‘681 patent) covering methods of treatment involving Eylea® (aflibercept).  PTAB invalidated claims 1, 3–11, 13, 14, 16– 24, and 26 of the patent for obviousness.  Samsung Bioepis filed its IPR petition in January 2023. 

As previously reported, in January 2024, the PTAB found the same claims of the ‘681 patent to be anticipated by a prior art journal publication, in  IPR2022-01225 commenced by Mylan in July 2022.  On 12 March 2024, Regeneron filed a notice of appeal in the United States Court of Appeals for the Federal Circuit challenging the PTAB’s findings in relation to the ‘681 patent (and a second Regeneron patent). 

Samsung Bioepis’ Opuviz and Biocon’s Yesafili® were both approved as biosimilars to Eylea® with interchangeability in May 2024. In BPCIA patent litigation brought by Regeneron against  Samsung Bioepis and Biocon/Mylan (amongst others), a preliminary injunction was issued in relation to Samsung Bioepis’ aflibercept biosimilar on 14 June 2024, while a permanent injunction was granted against Biocon/Mylan on 11 June 2024. 

June 13, 2024

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announced.   

Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.   

Over the last 9 months, a number of ustekinumab biosimilars have been launched, approved or recommended for approval: 

  • Amgen’s Wezlana® – approved in US (October 2023) and Australia (January 2024, and  PBS listed in April 2024), launched in Canada (March 2024), and received a positive recommendation from EMA’s CHMP (April 2024); 
  • Alvotech’s AVTO4 – approved in US (as Selarsdi®, with Teva, April 2024), Europe (as Uzpruvo®, with STADA, January 2024) and Japan (with Fuji Pharma, September 2023), and launched in Canada (as Jamteki®, with JAMP Pharma, March 2024); and 
  • Samsung Bioepis’ SB17 – approved in Europe and Korea (as Pyzchiva® and EpyztekTM, respectively, April 2024).  Samsung Bioepis is challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024. 

June 13, 2024

On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide.  Originator Novo Nordisk supplies liraglutide as Victoza® in EU which is indicated for the treatment of type 2 diabetes. Adalvo received approval via the decentralised procedure. 

According to Adalvo’s announcement, Victoza achieved over $4.8 billion in global sales in 2023. 

This news follows Biocon’s 27 March 2024 announcement of its approval of synthetic liraglutide in the UK. 

June 13, 2024

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma.  A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  Formycon says it expects the earliest market entry for FYB206 to be in 2029 in the US (after Keytruda’s market exclusivity expiry) and in 2030 in Europe.   

Other pembrolizumab biosimilars in clinical trials are Amgen’s ABP 234 (Ph 3 study in non-squamous NSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic non-squamous NSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials commenced in April/May 2024).  In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar.  Xbrane and Celltrion have also each previously announced a joint pembrolizumab biosimilar development. 

June 13, 2024

On 13 June 2024, at the Annual European Congress of Rheumatology, Celltrion announced positive Phase III results for CT-P47, a biosimilar referencing RoActemra®, in patients suffering from moderate-to-severe rheumatoid arthritis. The Phase III comparative clinical trial data showed that CT-P47 exhibits comparable efficacy and a similar safety and immunogenicity profile to the reference tocilizumab product. 

This news follows South Korean approval of Celltrion’s Steqeyma (CT-P43), a biosimilar to J&J’s Stelara® (ustekinumab). Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023. 

June 12, 2024

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours.  The trial (NCT06451497) is evaluating ZM008 alone and in combination with pembrolizumab.  ZM008 is a fully human IgG1 monoclonal antibody against LLT1 and disrupts LLT1’s interaction with CD16 receptor on natural killer cells. 

The FDA granted Zumutor’s Investigational New Drug (IND) application for ZM008 on 11 August 2023. 

June 11, 2024

On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion.   

Ono plans to leverage Deciphera’s oncology research and development capabilities, as well as its sales presence in Europe and the United States, to accelerate Ono’s global expansion.  

June 11, 2024

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed. 

As previously reported, following a December 2023 judgment that Biocon infringed eight claims of Regeneron’s US patent 11,084,864, a temporary restraining order was granted on 17 May 2024, and extended on 30 May 2024, preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The temporary order was made to preserve the status quo until the Court could determine the motion for a permanent injunction.  

Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023), Formycon (aBLA for FYB203 accepted by FDA in August 2023) and Samsung Bioepis (Opuviz FDA-approved in May 2024) in respect of alleged infringement of US Patent No. 11,084,855 (ophthalmic formulations of a VEGF antagonist). On 7 June 2023, Regeneron filed a preliminary injunction motion (under seal) against Amgen (aBLA for ABP 938 accepted by FDA in October 2023) in relation to the same patent. 

June 11, 2024

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.   

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive rights to commercialise AVT03 in Europe, Switzerland and the UK and exclusive rights in certain Central Asian and Middle Eastern countries. 

The companies’ November 2019 strategic partnership already covers: 

Under the June 2024 agreement, STADA’s commercialisation rights to the adalimumab and ustekinumab biosimilars will be extended to Commonwealth of Independent States (CIS).  Alvotech will regain commercial rights from STADA to AVT06, biosimilar to Regeneron’s Eylea (aflibercept), for which positive top-line results were reported in January 2024. 

June 11, 2024

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA).  Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement. 

Kevzara® is approved in 25 countries for moderately to severely active rheumatoid arthritis after a DMARD has been used and in the US for polymyalgia rheumatica in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. 

June 10, 2024

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 25 January 2025.  

Biogen reports that Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.  

June 6, 2024

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab).   

The new dosing regimen involves three additional IV doses for CD and UC patients commencing at week 10 of IV dosing.  The dose increase provides for as-needed escalation to 240 mg of RemsimaSC® maintenance therapy in CD patients and escalation in patients who have experienced decreased efficacy following 120mg of RemsimaSC®.   

RemsimaSC® has been approved in Europe since 2013.  In February 2024, Celltrion launched RemsimaSC® as Zymfentra® in the US 

June 4, 2024

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have therapeutic equivalence to Prolia®, with similar safety profiles.  

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab was accepted for review by the US FDA as biosimilar to Prolia®.   

May 31, 2024

On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD). 

This comes after the FDA accepted Dupixent® for priority review for the same indication in February 2024.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024. 

May 30, 2024

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June 2024. 

The analysis compared the proportion of patients with paroxysmal nocturnal hemoglobinuria (PNH) who remained transfusion-free when treated with SB12 or Soliris®.  Samsung Bioepis reports that the data “adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients”.   

Epysqli® (SB12) was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.   

Epysqli® is one of two eculizumab biosimilars approved in Europe, including Amgen’s Bekemv®, which was EMA approved in April 2023. 

Alexion filed proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).  In January 2024, Alexion also commenced US BPCIA litigation against Samsung Bioepis alleging infringement of 6 US eculizumab patents.   

May 30, 2024

On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea’s Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept).  Eydenzelt was approved for the same indications as Eylea® including wet macular degeneration and diabetic macular oedema. 

Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.  

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District Court (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.   

May 30, 2024

As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The purpose of the temporary order was to maintain the status quo until preliminary injunction motions were heard. 

On 30 May 2024, the temporary restraining order was extended for a further 14 days to allow additional time for the adjudication of the preliminary injunction motions.  Preliminary injunction motions are pending against each of Biocon, Celltrion, Formycon and Samsung Bioepis in respect of alleged infringement of US Patent No. 11,084,865 (ophthalmic formulations of a VEGF antagonist). 

May 30, 2024

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).   

The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU.  However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021. 

Avzivi® was FDA approved in December 2023. 

May 29, 2024

On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma.  The target action date for the FDA decision is 25 September 2024. 

This comes weeks after Amgen announced initiation of a Phase 3 study to evaluate its pembrolizumab biosimilar for advanced or metastatic no-squamous non-small cell lung cancer. 

May 29, 2024

On 29 May 2024, Merck (MSD) announced the acquisition of privately owned opthalmology focussed biotech EyeBio for US$3 billion, including an upfront payment of US$1.3 billion and $US1.7 billion in milestone payments.  The acquisition has been unanimously approved by EyeBio’s board, and is expected to close in Q3/2024. 

EyeBio’s lead candidate, Restoret™ (EYE103), is a tri-specific antibody for diabetic macular oedema (DME) and neovascular age-related macular degeneration and is expected to enter pivotal studies for DME in the second half of 2024.  

In March 2024, MSD completed its acquisition of Harpoon Therapeutics for about US$650M with the aim of augmenting and diversifying its oncology pipeline. 

May 28, 2024

On 28 May 2024, Amgen filed a complaint against Celltrion in the United States District Court for the District of New Jersey alleging infringement of 29 patents relating to denosumab.  The allegations relate to Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab). 

In May 2023, Amgen sued Sandoz in the US over its denosumab biosimilars (Jubbonti® and Wyost®) asserting infringement of 21 denosumab patents.  That dispute was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).   

Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively.  No other denosumab biosimilars have received US approval to date. 

May 28, 2024

On 28 May 2024, Bio-Thera and STADA announced they have entered an exclusive commercialisation agreement in relation to BAT2506, biosimilar to Janssen’s Simponi® (golimumab).   

Under the agreement, Bio-Thera has responsibility for developing and manufacturing BAT2506, while STADA has exclusive rights to commercialise the product in the EU, UK, Switzerland and certain other unnamed countries.  The agreement provides for an upfront payment to Bio-Thera of US$10M, plus milestone payments of up to US$147.5M, subject to fulfillment of certain conditions. 

This comes after last month’s announcement by Alvotech of positive topline results from a confirmatory clinical study of its golimumab biosimilar, AVT05. 

May 28, 2024

On 28 May 2024,  Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab).  Bkemv® is approved for the same indications as Soliris® (atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)) in the same dosage form and strength.   

Bkemv® is set to be launched in the US in March 2025, under a settlement reached by Amgen and Alexion in May 2020.   

Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® on 19 April 2023.  On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab. 

Alexion has also sued Samsung Bioepis in the UPC and the US alleging infringement of eculizumab patents. Samsung Bioepis’ SB12 (Epysqli®) was granted EU marketing approval in May 2023 and its aBLA was accepted by the FDA in July 2023 

May 28, 2024

On 28 May 2024, Outlook Therapeutics announced it received EU marketing authorisation for LYTENAVATM (ONS-5010, bevacizumab-gamma) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first authorised ophthalmic formulation of bevacizumab in the EU.  The marketing authorisation grants LYTENAVATM 10 years of EU market exclusivity. 

Outlook Therapeutics reports that it is aiming for the first commercial launch of the product in an EU Member State in Q1/2025. 

Outlook Therapeutics is also seeking approval for ophthalmic bevacizumab in the UK, with its MAA submitted on 13 May 2024, and the US, having resubmitted a BLA to the FDA in August 2022. 

May 27, 2024

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab has been accepted for review by the US FDA as biosimilar to Amgen’s Prolia®.  The biosimilar is to be indicated for osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer. 

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  Following the April 2024 resolution of US BPCI litigation, commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025. 

On 28 May 2024, Amgen commenced BPCIA litigation against Celltrion in the United States District Court for the District of New Jersey, alleging infringement of 29 patents relating to denosumab.  Celltrion applied to the FDA for marketing authorisation of its denosumab biosimilar, CT-P41, in December 2023. 

May 27, 2024

On 27 May 2024,  Eisai and Biogen announced that South Korea’s Ministry of Food and Drug Safety approved Leqembi® (lecanemab) for treating adults with mild cognitive impairment or mild Alzheimer’s disease.   

Leqembi® is reportedly the first approved treatment to reduce disease progression and slow cognitive and functional decline in patients with Alzheimer’s disease.  South Korea is the fourth country to approve Leqembi®, following the US in July/2023, Japan in September/2023, and China in January/2024

May 27, 2024

On 27 May 2024, Samsung Bioepis presented follow-up results from a Phase 3 study on SB16, biosimilar to Amgen’s Prolia® (denosumab).  According to Samsung Bioepis, the study demonstrated that switching postmenopausal osteoporosis patients from Prolia® to SB16 produced comparable results up to 18 months in terms of efficacy, safety and immunogenicity.  The results were presented at the 2024 European Calcified Tissue Society (ECTS) Congress in France. 

12-month results from the Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2023. 

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).   

May 27, 2024

On 27 May 2024, Boan Biotech announced that its Boluojia® (BA11021, denosumab injection, 120mg) received marketing approval from China’s National Medical Products Administration (NMPA) as biosimilar to Amgen’s Xgeva®.  Boluojia® is indicated for the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.  Boan Biotech reports that it intends to expand the approved indications for Boluojia® to include bone metastases from solid tumours and multiple myeloma. 

Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia® (denosumab), was approved by China’s NMPA in November 2022 for postmenopausal women with osteoporosis at high risk of fractures. 

In January 2024, Boan Biotech completed enrolment for its international, multi-centre, phase 3 studies of Boluojia® and Boyoubei®, which are being conducted simultaneously in Europe, the US and Japan. 

May 24, 2024

On 24 May 2024, Shanghai Henlius and Organon announced that the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab as biosimilars to Amgen’s Prolia® and Xgeva®.  The applications are based on Phase 3 trials confirming HLX14 is equivalent in efficacy, safety, tolerability and immunogenicity to Prolia® in postmenopausal women with osteoporosis at high risk for fracture.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

This news comes two days after the European Commission approved Sandoz’s Wyost® and Jubbonti® as the first EU denosumab biosimilars.

May 23, 2024

On 23 May 2024, Celltrion announced that the European Commission has approved its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).

Omlyclo® is the first omalizumab biosimilar approved in Europe.  No omalizumab biosimilars have been approved to date in the US.  This follows the positive opinion adopted by the CHMP of the European Medicines Agency in relation to Omlyclo® on 22 March 2024.

Celltrion is defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.

Celltrion submitted an A-BLA in the US for its omalizumab bioximilar (CT-P39) in March 2024, in Canada in December 2023, and in Korea in June 2023.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

May 22, 2024

Biocon Limited announced on 24 May 2024 that it signed an exclusive licensing and supply agreement with Korea’s Handok Inc for the commercialisation in South Korea of its synthetic liraglutide, biosimilar to Novo Nordisk’s Victoza®.

Under the terms of the agreement, Biocon will be responsible for the development, manufacturing and supply of the drug product, and Handok will manage regulatory approvals and commercialisation in the South Korean market.

Biocon’s liraglutide became the first approved biosimilar to Novo Nordisk’s Victoza® in the UK in March 2024.

May 22, 2024

On 22 May 2024, the European Commission approved the first denosumab biosimilars in Sandoz’s Wyost® and Jubbonti®.  The biosimilars were approved with a full indication set mirroring the approved indications of Amgen’s Xgeva® and Prolia® respectively, and have the same dosage form, route of administration, dosing regimen and presentation as the reference medicines.

Sandoz expects to launch the biosimilars in Europe “from November 2025”.

On 5 March 2024, Sandoz’s Wyost® and Jubbonti® became the first denosumab biosimilars approved in the US with interchangeability to the reference products.  As a result of settlement of pending BPCIA proceedings in the US in April 2024, Sandoz can launch its biosimilars in the US from 31 May 2025 (or earlier in certain circumstances).

Jubbonti® was approved in Canada on 20 February 2024.

Other denosumab biosimilars have been approved in China including Prolia® biosimilars Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), and Mabwell’s Xgeva® biosimilar MaiweijianTM (denosumab 120mg) (April 2024). Companies that have denosumab biosimilars under development include Samsung Bioepis, Celltrion, Alvotech, Intas, and Shanghai Henlius Biotech.

May 21, 2024

On 21 May 2024, Alvotech provided its financial results for Q1 2024, reporting total revenues of US$37 million compared to US$16M for the same quarter in 2023.

Alvotech reports its highlights for Q1/24 as:

Regarding its pipeline, Alvotech reports positive top-line results from studies on AVT05 (golimumab) biosimilar to Simponi® and Simponi Aria® and  AVT06 (aflibercept), biosimilar to Eylea® , with the company being “on track to file marketing applications for at least three biosimilar candidates in the second half of this year”.

May 21, 2024

On 21 May 2024, Alvotech and Dr Reddy’s announced that that they have entered into a licence and supply agreement for the commercialisation of AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in the US, EU and UK.

Under the agreement, Alvotech will develop and manufacture the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.  The agreement provides for an up-front payment to Alvotech, with additional payments upon certain regulatory and commercialisation milestones, plus sales-based payments.

Alvotech announced positive top-line results for AVT03 in January 2024, in a study comparing the pharmacokinetics, safety and tolerability of the biosimilar compared to Prolia® in healthy adults.

May 21, 2024

As previously reported, in the context of the ongoing US aflibercept litigation, Regeneron previously filed motions for preliminary injunctions against each of Celltrion, Formycon and Samsung Bioepis.  On 21 May 2024, Regeneron withdrew its preliminary injunction motions in respect of all patents other than US Patent No. 11,084,865 (relating to ophthalmic formulations of a VEGF antagonist) “[i]n an effort to streamline the issues in dispute”.

The Court previously determined that Biocon infringed eight claims of Regeneron’s US patent 11,084,865 in a judgment delivered on 27 December 2023 and published on 31 January 2024.  Based on that decision, a temporary 14 day restraining order was granted on 17 May 2024, preventing Biocon from manufacturing, using, marketing and selling its Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron

This news follows Regeneron’s filing of a second complaint against Celltrion on 17 May and the FDA’s approval on 20 May 2024 of Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf), the first interchangeable biosimilars to Regeneron’s Eylea® approved in the US.

May 21, 2024

On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant improvements on a number of endoscopic endpoints when compared to both Stelara® (ustekinumab) and placebo.

As previously reported, J&J is seeking EMA approval to expand its marketing authority for Tremfya® to include treatment of adult patients with moderate to severe UC and moderate to severe CD.

May 21, 2024

On 21 May 2024, Celltrion announced positive two-year results from its extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for Zymfentra™ (infliximab-dyyb) in adults with moderately to severely active Crohn’s disease and ulcerative colitis after induction with intravenous infliximab.   Celltrion reports that the findings support the long-term efficacy and safety of Zymfentra™.

Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA in October 2023.  Celltrion launched Zymfentra in the US in March 2024.  A formulation patent for Zymfentra was granted in the US on 9 April 2024.

May 20, 2024

On 20 May 2024, Samsung Bioepis and Biocon won the race to be the first FDA approved interchangeable biosimilars to Regeneron’s Eylea®(aflibercept). Both Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf) are approved for nAMD, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema.

The US launch dates for the products remain uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis and Biocon (amongst others) regarding aflibercept.  As previously reported, on 17 May 2024, a temporary (14 day) restraining order was granted against Biocon, preventing it from manufacturing, using, marketing and selling its Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron.

In March 2024, Biocon announced a settlement with Regeneron and Bayer under which it can launch Yesafili in Canada from 1 July 2025.  Biocon has also received marketing approval for Yesafili in the UK (November 2023) and the EU (September 2023).

Samsung Bioepis’ Afilivu® (SB15, aflibercept) received Korean approval in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

May 20, 2024

On 20 May 2024, Teva and Alvotech announced that their interchangeable high concentration citrate-free adalimumab biosimilar Simlandi® (adalimumab-ryvk, AVT02) is now available in the US.  Simlandi® is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Simlandi® was FDA approved in February 2024 as the first interchangeable, high-concentration, citrate-free biosimilar to Humira.  Alvotech reports that nearly 88% of adalimumab prescriptions in the US are for the high-concentration formulation.

In July 2023, Teva and Alvotech announced a $40 million expansion to their US biosimilar partnership.  The agreement involved milestone payments and shared profits from the commercialisation of the biosimilars.

May 20, 2024

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiving Tremfya® (guselkumab) achieved clinical remission at 44 weeks compared to placebo-treated patients.   

Tremfya® is currently approved in the US and Europe for treatment of severe plaque psoriasis and psoriatic arthritis.  In March 2024, Johnson & Johnson submitted an sBLA to the FDA for Tremfya® for moderately to severely active ulcerative colitis.  This is part of a strategy to expand into inflammatory bowel disease indications. 

May 20, 2024

On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of  Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of Medicine on 21 May 2024 and reportedly demonstrate that Dupixent reduced exacerbations by 34% and improved lung function compared to placebo.   Previously, on 13 May 2024, Regeneron and Sanofi announced that the FDA accepted for priority reviewtheir sBLA for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). 

May 17, 2024

On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications:

The new cervical cancer approval is based on the KEYNOTE-A18 study and comes after MSD received Korean approval for Keytruda in April 2024 for patients with FIGO 2014 stage III-IVA cervical cancer in combination with chemotherapy.

The new NSCLC indication is based on the KEYNOTE-091 study and increases to six the number of on-label NSCLC indications for Keytruda in Korea.

May 17, 2024

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®, were valid and infringed by Mylan and Biocon.  On 17 May 2024, Judge Kleeh granted a temporary restraining order, prohibiting Mylan/Biocon from manufacturing, using, marketing and selling their Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron.  The restraining order operates for 14 days, unless otherwise extended.

Regeneron’s proceedings against Mylan and Biocon are one of six US actions brought by Regeneron regarding aflibercept biosimilars, with the other actions involving Amgen, Celltrion, Samsung Bioepis (2 actions) and FormyconAll proceedings are centralised in the Northern District of West Virginia and are ongoing.  A hearing scheduled for 2 May 2024 regarding a motion by Regeneron for a permanent injunction again Mylan/Biocon and motions for preliminary injunctions against Celltrion, Formycon and Samsung Bioepis, was cancelled by order dated 26 April 2024.  A scheduling conference was held on 17 May 2024, the transcript for which is not yet publicly accessible.

May 17, 2024

On 17 May 2024, Regeneron filed a second complaint against Celltrion in the US District Court for the Northern District of West Virginia asserting infringement of 25 US patents relating to aflibercept (including method of treatment, formulation and manufacturing claims).  Regeneron’s first complaint against Celltrion was filed in November 2023, alleging infringement of 38 patents, including the 25 patents asserted in the second complaint. 

Both complaints relate to Celltrion’s aBLA filed with the FDA on 29 June 2023 for CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept).  The first complaint was filed after Regeneron had provided Celltrion with its list of patents as part of the BPCIA patent dance procedure and the second complaint was filed after the parties completed that procedure and agreed on the patents to be litigated. 

The second Celltrion Complaint is the seventh US proceeding brought by Regeneron in relation to aflibercept biosimilars, the others being against Amgen, Mylan, Celltrion (1st action), Samsung Bioepis (2 actions) and Formycon.  All proceedings remain pending. 

May 16, 2024

On 16 May 2024, the FDA granted accelerated approval to Amgen’s IMDELLTRATM (tarlatamab-dlle) for small cell lung cancer that has progressed on or after platinum-based chemotherapy.  Tarlatamab is a Bispecific T-cell Engager (BiTE®) molecule designed to engage a patient’s own T cells to attack DLL3-expressing tumour cells. 

The FDA granted priority review to Amgen’s tarlatamab BLA in December 2023. 

May 15, 2024

On 15 May 2024, Formycon announced its partnership with MS Pharma in MENA for the commercialisation of its aflibercept biosimilar FYB203.  Klinge Pharma GmbH, which holds the global commercialisation rights for Formycon’s FYB203, granted MS Pharma exclusive rights to license, commercialise, and produce FYB203 in Saudi Arabia for the Middle East and North Africa (MENA).

MS Pharma markets Formycon’s Ravegza® (FYB201, ranibizumab) in the MENA region.

In June 2023, the FDA accepted Formycon’s BLA for FYB203 and its MAA application was accepted by EMA in December 2023.

May 14, 2024

During the first case management of this case in the Federal Court of Australia on 14 May 2024, it became clear that Cipla is challenging the patent term extension (PTE) on Novo Nordisk’s liraglutide formulation patent (AU 2004290862). The 9-month PTE was granted on 4 August 2011 and is due to expire on 26 August 2025.  If Cipla succeeds in its challenge, the expiry date will become 18 November 2024.   

According to submissions made in open Court, pending timely and favourable resolution of its challenge, Cipla plans to launch liraglutide biosimilar on 19 November 2024.   

A three-day substantive hearing has been scheduled for the end of October 2024.  

This follows the Indian launch of a liraglutide biosimilar, Glenmark’s Lirafit® in January this year and the approval in the UK of Biocon’s liraglutide biosimilar in March 2024.  

May 13, 2024

On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).   The target action date for the FDA decision is 15 September 2024.  If the new indication is approved, it will be the first treatment in the US for adolescents with inadequately controlled CRSwNP.

This is the second sBLA for Dupixent® accepted for priority review this year, with an sBLA for a 6th indication of uncontrolled COPD in adults accepted in February 2024.

May 13, 2024

On 13 May 2024, Outlook Therapeutics announced that it submitted a Marketing Authorisation Application (MAA) in the UK for its ophthalmic formulation of bevacizumab (ONS-5010, LYTENAVA™) for the treatment of wet AMD. Outlook Therapeutics is seeking to achieve FDA, EU and MHRA approval for the launch of bevacizumab as the first approved ophthalmic formulation of bevacizumab, which has been used off label for ophthalmic conditions for many years.  Outlook Therapeutics suggests that approval may also be sought in Japan, other EU markets, and elsewhere.

The UK submission follows the positive opinion for LYTENAVA™ issued by the EU’s Committee for Medicinal Products (CHMP) on 22 March 2024.  The International Recognition Procedure allows MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from the European Union, Australia, Canada, Japan, Switzerland, Singapore and/or the United States.

May 13, 2024

On 13 May 2024, Boehringer Ingelheim (BI) announced a partnership with Cigna subsidiary Quallent Pharmaceuticals, under which Quallent will distribute high and low-concentration forms of BI’s citrate-free adalimumab biosimilar in the USA under its private label.  BI will continue to market its adalimumab products.

BI’s high concentration Cyltezo® was approved by the FDA in May 2024 and a low concentration formulation has been on the US-market since July 2023.

BI is the second Humira® biosimilar manufacturer to partner with Quallent, with Alvotech announcing last month its US partnership with Quallent to supply  Alvotech’s high-concentration interchangeable adalimumab biosimilar.

May 13, 2024

On 13 May 2024, Novo Holdings A/S announced the acquisition of a 60% majority stake in growing Austrian life sciences tools company Single Use Support.   The two co-founders of Single Use Support will each retain a 10% stake, and Danaher Corporation will hold the remaining 20%.

Founded in 2017 in Austria, Single Use Support develops equipment and consumables for bioprocessing, focusing on biological drug substances, cell and gene therapies, and mRNA vaccines.

This news follows the 25 March 2024 announcement by Novo Nordisk of its acquisition of Cardior Pharmaceuticals for (up to) € 1.025B.

May 13, 2024

On 13 May 2024, Novo Nordisk announced positive results from the FRONTIER 2 trial, a 26-week phase 3a study evaluating the efficacy and safety of once-weekly and once-monthly subcutaneous administration of Mim8 for the treatment for haemophilia A.  The study demonstrated that Mim8, a FVIIIa bispecific antibody, significantly reduced treated bleeding episodes across both treatment groups and was found to be safe and well-tolerated.

Novo Nordisk plans to seek regulatory approval for Mim8 by late 2024 and will present additional data in upcoming conferences and publications.

This news follows the 10 April 2024 announcement of Novo Nordisk’s partnership with Ginkgo Bioworks.

May 10, 2024

On 6 May 2024, by order unsealed on 10 May 2024, the United States District Court for the District of Delaware refused to grant Alexion injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating paroxysmal nocturnal hemoglobinuria (PNH) (US 10590189) and atypical haemolytic uremic syndrome (aHUS) (US 9447176) with eculizumab.  The patents are due to expire on 8 September 2027 and 22 August 2032, respectively. 

The PI application was part of the BPCIA litigation commenced by Alexion on 3 January 2024 alleging infringement of 6 patents relating to Samsung Bioepis’ aBLA for SB12, its biosimilar to Alexion’s Soliris® (eculizumab).  The litigation is ongoing. 

Alexion also filed proceedings on 19 March 2024 against Samsung Bioepis (and Amgen) in the Hamburg Local Division of the UPC seeking provisional measures in relation to EP 3 167 888 (method of treating PNH). 

SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024. 

May 10, 2024

On 10 May 2024, Xbrane and Stada announced the exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate.

Swedish biosimilar developer Xbrane and Germany’s STADA are responsible for completing the regulatory approval process for the ranibizumab candidate, and Xbrane is responsible for commercial manufacturing and supply. Valorum will be responsible for US commercialisation efforts for the product which is expected to be supplied as Lucamzi™.

On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA. Xbrane has not yet announced a resubmission date for the BLA.

May 9, 2024

On 9 May 2024, Rani Therapeutics announced that it will present pre-clinical and clinical data at Digestive Disease Week in the US (18-21 May 2024) regarding RT-111, an oral delivery platform known as the RaniPill® capsule, containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The title of one of the abstracts to be presented suggests that the RaniPill® was found to reliably and safely deliver ustekinumab with high bioavailability relative to subcutaneous ustekinumab in healthy human participants.

On 5 February 2024, Rani Therapeutics published positive topline results from a phase 1 clinical trial of RT-111.  In June 2023, Rani expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), in addition to RT-111.

May 8, 2024

On 8 May 2024, Telix announced an agreement with Cardinal Health Nuclear & Precision Health Solutions for the global clinical supply of actinium-225 (Ac-225). This therapeutic radioisotope will support the development of Telix’s targeted alpha therapy (TAT) pipeline.

May 7, 2024

On 7 May 2024, Galderma announced that its nemolizumab, for the treatment of prurigo nodularis and for moderate to severe atopic dermatitis has been accepted for review in Australia, Singapore, Switzerland and the UK under the Access Consortium Framework, a collaboration between regulatory authorities of those four countries plus Canada.  Galderma expects to receive an approval decision from the Consortium in 2025. 

Regulatory filings for nemolizumab were accepted by the FDA and EMA in February 2024. 

May 7, 2024

On 7 May 2024, the EU Medicines Agency (EMA) withdrew marketing authorisation (MA) approval for AZ’s COVID-19 vaccine Vaxzevria, at AZ’s request. AZ requested   the withdrawal reportedly due to decline in demand for the vaccine and it no longer being manufactured or supplied.

Vaxzevria was co-developed with Oxford University as a Covid-19 vaccine and was manufactured by CSL. Vaxzevria was granted conditional MA for immunisation against Covid-19 on 29 January 2021 and then granted a 5-year standard MA on 31 October 2022. According to CNN Business, AZ has supplied more than 3 billion vaccine doses globally since 2021.

May 7, 2024

On 7 May 2024, Pharma In Focus reported that Arrotex has partnered with Amgen to promote Amgen’s Prolia® (denosumab) in Australia.  It is planned that the partnership “will support the future growth of Prolia in the Australian market, utilising the infrastructure and reach of Arrotex to further the patient, pharmacist and prescriber experience”.  It is unclear when the agreement will take effect.

There are no Prolia® (denosumab) biosimilars approved in Australia to date.  Prolia® biosimilars have been approved in the US (Sandoz’s Jubbonti®, March 2024), Canada (Jubbonti®, February 2024) and China (Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023)).

May 7, 2024

On 7 May 2024, Sandoz announced Q1 2024 net sales of USD1.9 billion, with its biosimilars growing 21% to USD 623 million.  The biosimilar growth is said to be driven by Sandoz’s 2023 US/EU launch of Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab), and the acquisition of Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), announced in January 2024.  During the reported quarter, Sandoz also launched in Germany the Polpharma-developed Tyruko® (Biogen’s Tysabri®, natalizumab) and obtained US approval for Jubbonti® and Wyost® (Amgen’s Prolia®/Xgeva®, denosumab).

May 6, 2024

On 6 May 2024, Calliditas announced positive Phase 2 results for Setanaxib and Pembrolizumab for the treatment of head and neck cancer.  The trial was randomized, placebo-controlled, and double-blinded and patients completed at least 15 weeks of treatment with 800mg setanaxib administered twice daily with 200mg pembrolizumab administered intravenously every three weeks.  Reportedly, the study showed significant improvements in both progression-free survival (PFS) and overall survival (OS), along with notable changes in tumour biology. 

Calliditas is conducting further Phase 2 setanaxib trials for treating primary biliary cholangitis, idiopathic pulmonary fibrosis, and Alport syndrome. 

May 3, 2024

On 3 May 2024, Indian-headquartered Lupin, in partnership with Sandoz, announced its Canadian launch of etanercept biosimilar Rymti®, biosimilar to Amgen’s Enbrel®, with a full indication set.  Rymti® is supplied in a pre-filled pen and syringe and is Lupin’s first biosimilar launched in Canada.  Rymti® was approved in Canada in September 2022 following approval in Australia and Europe (where it is known as Nepexto®) in 2020.

May 2, 2024

On 2 May 2024, Amgen revealed that it initiated a Phase 3 study to compare the efficacy, pharmacokinetics, safety and immunogenicity of its pembrolizumab biosimilar, ABP 234, with Keytruda® in patients with advanced or metastatic non-squamous non-small cell lung cancer.

In April 2024, Samsung Bioepis announced commencement of Ph 3 clinical trials for its pembrolizumab biosimilar, SB27, and in March 2024, Korea Biomedical Review reported that  Rophibio entered into an agreement with US biotech Avantor  in relation to the development of a pembrolizumab biosimilar.  Formycon, Xbrane, and Celltrion have each previously announced their development of pembrolizumab biosimilars.

May 2, 2024

On 2 May 2024, Celltrion announced that it has won a 12 month tender to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) and Herzuma®, biosimilar to Roche’s Herceptin® (trastuzumab), in Peru.  Celltrion expects to capture 86% of Peru’s infliximab market and 50% of Peru’s trastuzumab market.  Remicade® will be supplied from the end of May while Herzuma® will be supplied from July 2024.

This follows Celltrion’s recent tender successes regarding Remsima SC® in Denmark(April 2024), Norway (February 2024), and Sicily (January 2024).  In February 2024, Celltrion also secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar).   These contracts effectively secured more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market.

May 1, 2024

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.  This follows news of its US sBLA submission on 11 March 2024 for guselkumab for the treatment of moderately to severely active ulcerative colitis.

Tremfya® (guselkumab) is approved in Europe for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

May 1, 2024

On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically significant and clinically meaningful improvement, meeting its dual primary endpoint of overall survival.

In May 2021, the FDA approved Ketyruda® in combination with trastuzumab and chemotherapy for first line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.  The indication was approved under the FDA’s Accelerated Approval Program, which requires that studies are conducted to confirm the anticipated clinical benefit.  MSD reports that the final results from the KEYNOTE-811 trial will determine if Keytruda will receive continued FDA approval for the gastric cancer indication.

In February 2024, Keytruda® (with trastuzumab and chemotherapy) was approved in Canada for the same gastric cancer indication, based on earlier results of the KEYNOTE-811 study in relation to its dual primary endpoint of progression-free survival.

May 1, 2024

On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie’s Humira® (adalimumab)), for multiple chronic inflammatory diseases.

BI now has approvals for the high (100 mg/mL) and low (50 mg/mL) concentration formulations of Cyltezo®, the latter on market since July 2023.  The newly approved high-concentration formulation of Cyltezo® is available in pre-filled syringes and autoinjectors.  Cyltezo® is priced 5% lower than Humira® and the unbranded biosimilar Adalimumab-adbm is offered at a price of 81% less than Humira®.

Alvotech and Teva’s Simlandi® received FDA approval on 24 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA.  FDA has also approved Samsung Bioepis’ Hadlima, Amgen’s Amjevita, Sandoz’s Hyrimoz, and Celltrion’s Yuflyma, as high concentration formulations.

April 30, 2024

On 30 April 2024, Alvotech announced a strategic partnership with Quallent Pharmaceuticals Health, under which a high-concentration interchangeable biosimilar to Humira® manufactured by Alvotech will be distributed under Quallent’s private-label.  This partnership aligns with Alvotech’s existing U.S. commercialisation agreement with Teva.

Alvotech and Teva’s Simlandi® received FDA approval on 24 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA.

April 29, 2024

The Korean Biomedical Review has reported that Samil Pharmaceutical will launch Samsung Bioepis’ aflibercept in Korean market from 1 May 2024.  Samil and Samsung Bioepis entered into a B2B commercialisation deal for biosimilar aflibercept in February 2024, following their agreement for biosimilar ranibizumab in June 2022.

April 29, 2024

On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.

The following biosimilars have been recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

  • Amgen’s Wezlana® (ustekinumab); and
  • Celltrion’s Yuflyma® (adalimumab) and Vegzelma® (bevacizumab).

In addition, the following biopharmaceuticals have been recommended for first time listing on the PBS:

  • AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for the treatment of patients with HER2-low unresectable or metastatic breast cancer, and Saphnelo® (anifrolumab) for the treatment of patients with severe systemic lupus erythematosus with high disease activity despite standard of care;
  • UCB’s Bimzelx® (bimekizumab) for the treatment of severe psoriatic arthritis;
  • new forms of Janssen-Cilag’s Stelara® (ustekinumab), as 45 mg and 90 mg pre-filled syringe (PFS) and pre-filled pen (PFP); and
  • a new subcutaneous form and strength of Roche’s Tecentriq® (atezolizumab).

PBAC reports that applications for an Authority Script PBS listing of Regeneron’s Eylea® (aflibercept) for the treatment of patients with visual impairment due to DMO and for the treatment of visual impairment caused by CNV secondary to AMD are to be considered at a “future” PBAC meeting.

April 29, 2024

On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma.  This is the first US biosimilar approved for Accord BioPharma.

The approval relates to the 150mg dose product with the FDA decision on the 420mg dose expected in the fourth quarter of 2024.

Accord BioPharma has submitted BLAs for biosimilars of pegfilgrastim, filgrastim, and ustekinumab with launch of the latter licensed under a settlement with Janssen from 15 May 2025.

April 29, 2024

On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.

This concludes the District Court proceedings Amgen commenced against Sandoz in New Jersey on 1 May 2023 alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva®.  The proceedings followed the FDA’s acceptance of Sandoz’s BLA for Jubbonti® and Wyost® in February 2023.

Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively.  No other denosumab biosimilars have received US approval to date.

In March 2024, the CHMP of the European Medicines Agency adopted a positive opinion for Sandoz’s denosumab biosimilars.  Jubbonti® was approved in Canada on 20 February 2024.  Other denosumab biosimilars have been approved in China: Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), both biosimilars to Prolia®, and Mabwell’s MaiweijianTM (denosumab 120mg) (April 2024), biosimilar to Xgeva®. Companies that have denosumab biosimilars under development include Samsung BioepisCelltrion, Alvotech, Intas, and Shanghai Henlius Biotech.

April 27, 2024

A paper published in the Journal of the American Academy of Dermatology on 27 April 2024 reported that, in a Phase 3 clinical trial sponsored by Samsung Bioepis, SB17 (ustekinumab) was biosimilar to Janssen’s Stelara® (in terms of efficacy, safety, pharmacokinetics, and immunogenicity) for the treatment of moderate to severe psoriasis.

Samsung Bioepis’ SB17 was approved in April 2024 in Europe (as Pyzchiva®) and Korea (as EpyztekTM).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

April 25, 2024

On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche’s RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).  The recommendation relates to the IV formulation of tocilizumab for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.  The Biogen application was accepted by EMA 19 months earlier in September 2022.

The product, previously known as BAT1806, was developed by Bio-Thera, and Biogen acquired exclusive rights in all countries other than China in a deal announced in April 2021.

This follows the FDA approval of Biogen’s Tofidence™ on 30 September 2023, and the US patent settlement between Roche, Genentech, Chugai and Biogen in October 2023.

April 25, 2024

On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen’s Wezenla™ (ustekinumab), biosimilar to Janssen’s Stelara®.   Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injection, as well as a 130 mg solution for infusion.

Amgen’s Wezlana™ was approved in the US in October 2023, was launched in Canada in March 2024 and was listed on the Australian PBS in January 2024.

CHMP’s positive recommendation for Wezenla™ comes days after Samsung Bioepis’ Pyzchiva® (ustekinumab) was approved in the EU on 25 April 2024.

April 25, 2024

On 25 April 2024, Evernorth, a provider of health services and member of the Cigna Group, announced that it will offer biosimilar adalimumab to US patients with no patient out-of-pocket costs from June 2024, resulting in savings to the patient of around US $3,500 per year . This biosimilar will be accessible to eligible patients through its specialty pharmacy, Accredo.

The first Humira® biosimilar [Amgen’s Amjevita], was launched in the US on 31 January 2023, with multiple additional biosimilars entering the US market in July 2023.

April 24, 2024

On 24 April 2024, the FDA released an updated draft guidance document  on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products  seeking input from industry by 25 June 2024.

The revised guidance largely maintains the content from the 2020 version but seeks to “addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k))”.

Comments on the draft guidance can be submitted here until 25 June 2024.

April 24, 2024

On 24 April 2024, Alvotech announced positive topline results from a confirmatory clinical study of AVT05 (golimumab), with the biosimilar demonstrating therapeutic equivalence to Janssen’s Simponi® and Simponi Aria® in patients with moderate to severe rheumatoid arthritis.

Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®.

These results follow Alvotech’s announcement in November 2023 that its pharmacokinetic study for AVT05 met its primary endpoint.

April 24, 2024

On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC) has become publicly available.

The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each of Samsung Bioepis (Case No. ACT_13849/2024) and Amgen (Case No. ACT_13886/2024).  Alexion is seeking provisional measures in relation to EP 3 167 888, which concerns a method of treating paroxysmal nocturnal hemoglobinuria using eculizumab, marketed by Alexion as Soliris®.

Samsung Bioepis obtained EC marketing authorisation for Epysqli® (eculizumab) on 30 May 2023 and launched it in 3 European countries in October 2023.  Amgen obtained EMA approval for Bekemv® (eculizumab) on 19 April 2023.

Alexion is also suing Samsung Bioepis in the US, asserting infringement of six US eculizumab patents and has been in dispute with Amgen in Germany, with the Munich Higher Regional Court overturning Alexion’s preliminary injunction order regarding Amgen’s off label-use of Bekemv® in February 2024.

The second set of UPC biosimilar disputes was commenced on 9 April 2024 in the Dusseldorf Local Division by Novartis and Genentech (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion.  The actions relate to EP 3 805 248, regarding pharmaceutical formulations of omalizumab, marketed by Novartis and Genentech as Xolair®.  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Celltrion’s omalizumab biosimilar, Omlyclo®, on 22 March 2024.

April 24, 2024

Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products.

Biosimilar highlights for Q1 2024 are reported to be the EC approval in April 2024 of Pyzchiva® (SB17, biosimilar to Janssen’s Stelara® (ustekinumab)); the Korean approvals of EpzystekTM (SB17, ustekinumab) in April 2024, Afilivu® (SB15, biosimilar to Regeneron’s Eylea® (aflibercept)) in February 2024, and Episcli® (SB12, biosimilar to Alexion’s Soliris® (eculizumab)) in January 2024; the initiation of a global phase 1 clinical trial for SB27 (biosimilar to MSD’s Keytruda® (pembrolizumab)) in February 2024; and commencement of direct sales in Korea of SB2 (infliximab), SB4 (etanercept) and SB5 (adalimumab).

April 22, 2024

On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab).  The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.

Pyzchiva® is one of the first ustekinumab biosimilars approved in Europe, following the approval of Alvotech’s and Stada’s Uzpruvo® in January 2024.  Three days after Pyzchiva® was approved, on 25 April 2024, the CMP issued a positive recommendation for the marketing authorisation of Amgen’s ustekinumab biosimilar, Wezenla™. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

Earlier this month, Samsung Bioepis received Korean approval for EpyztekTM, the first ustekinumab biosimilar approved in Korea.  Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

April 21, 2024

On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM.  The issues identified primarily concern (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.  The FDA has not requested additional clinical studies to demonstrate biosimilarity and has not requested reinspection of any site.

Xbrane will subsequently announce a resubmission date for the ranibizumab BLA.

April 20, 2024

Dr Reddy’s announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for biosimilar rituximab (DRL_RI), biosimilar to Genentech/Biogen’s Rituxan®.   The CRL is said to relate to the ongoing resolution of results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”. 

In April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab. 

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020)Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

April 19, 2024

On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma in combination with fluoropyrimidine and platinum-based chemotherapy.

Keytruda® was approved for the same indication in the US in November 2023 and in Korea in March 2024, while a positive CHMP recommendation was received in Europe in October 2023.

April 19, 2024

On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February 2023.  Teva will continue to commercialise adalimumab-ryvk under the SIMLANDI® brand in the US pursuant to its existing strategic partnership with Alvotech, which remains unchanged.

April 19, 2024

On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada’s approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen’s NEULASTA®.

This follows Coherus’ launch of Udenyca Onbody® another biosimilar to Amgen’s NEULASTA® on 21 February 2024.

Peg-filgrastim was one of the first approved biosimilar molecules, and it is interesting to see new biosimilars approved 22 years after the first US approval in 2002.

April 18, 2024

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).

This follows the FDA’s acceptance of Takeda’s BLA for ENTYVIO® for the same indication, and the FDA’s approval of ENTYVIO® for ulcerative colitis (UC), in September 2023.

Vedolizumab biosimilars have previously been reported to be in development by Polpharma Biologics, Alvotech(under an agreement with Advanz) and Bio-Thera.

April 18, 2024

On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®.  Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion’s Danish subsidiary. This subsidiary is planning to expand its marketing team and initiate marketing activities to increase the prescription rate of the product.

This comes after Celltrion’s successful bids for the supply of Remsima SC® (infliximab) in the Netherlands and Norway earlier this year.

April 17, 2024

On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil.  Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and commercialisation strategies in Brazil.

This follows news earlier this month that Hangzhou Jiuyan Gene Engineering’s application for a generic version of Ozempic® (semaglutide) was accepted by regulators in China.

April 16, 2024

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.

This is the second US biosimilar approved under the strategic agreement between Teva and Alvotech, following the FDA approval of Simlandi® (adalimumab) as an interchangeable biosimilar to AbbVie’s Humira® in February.

SELARSDI™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023.

April 16, 2024

The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO (International Federation of Genecology and Obstetrics) 2014 stage III-IVA cervical cancer.

The same indication was approved in the US by the FDA in January 2024.  This followed the FDA approval in October 2021 for Keytruda® plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

April 15, 2024

On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab) in an intravenous formulation. Both IV and subcutaneous forms of Tyenne were FDA approved on 5 March 2024. Tyenne is the third biosimilar product Fresenius Kabi has launched in the US.

Fresenius Kabi launched Tyenne® in Europe as the first to market biosimilar in November 2023 in both IV and subcutaneous formulations.

April 15, 2024

The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024.  It is reported that the clinical trial showed CT-P41 has equivalent efficacy, pharmacokinetics and safety to Prolia® in postmenopausal women with osteoporosis.

Celltrion applied to the FDA for marketing authorisation of CT-P41 in December 2023.  The first Prolia® (denosumab) biosimilar approved in the US was Sandoz’s Jubbonti®, on 5 March 2024.

Prolia® (denosumab) biosimilars have been approved in Canada (Sandoz’s Jubbonti® on 20 February 2024) and China (Boan Biotech’s Boyoubei® in November 2022 and Mabwell’s Mailishu® in March 2023).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech.

April 12, 2024

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held 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 aflibercept method of treatment patents (11,253,572 and 10,880,601) to be invalid.  Regeneron appealed and Mylan and Biocon filed cross-appeals.

On 12 April 2024, the Court of Appeals for the Federal Circuit dismissed the appeal and cross-appeals on the basis that all parties agreed that the Appeals Court lacked jurisdiction pending a decision of all patents in dispute.  This was agreed because only three patents out of the 24 asserted by Regeneron had been addressed in the 27 December 2023 decision and the infringement and validity of numerous patent claims are still pending in the proceeding.

A hearing of Regeneron’s motion for a permanent injunction following the Court’s decision that Mylan/Biocon infringe US 11,084,865 is scheduled for 2 May 2024, ahead of a status conference on 13 May 2024.

April 12, 2024

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions of fact” and should be centralized in the Northern District of West Virginia.

Regeneron commenced five of its actions in the Northern District of West Virginia but commenced proceedings against Amgen in the Central District of California.  The Amgen case will now be transferred and assigned to Judge Kleeh who is hearing the remainder of the actions.

There are 63 patents in issue across each of the six actions.  In each case, Regeneron alleges infringement of a common set of 13 US patents covering its ophthalmic drug, Eylea® (aflibercept).

Of the common set of 13 patents, one (a formulation patent, US 11,084,865, expiring in June 2027) was held by Judge Kleeh to be valid and infringed in a decision issued in the first-filed Mylan action in December 2023.  Seven of the patents are at issue in preliminary injunction proceedings due to be heard on 2 May 2024 in the Northern District of West Virgina actions against Celltrion, Samsung Bioepis and Formycon.

April 12, 2024

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  EpyztekTM is the first ustekinumab biosimilar approved in Korea.

Samsung Bioepis presented Phase 3 results for SB17 at the American Academy of Dermatology Annual Meeting last month, demonstrating equivalence to Stelara® in efficacy and safety.

Under the brand name PyzchivaTM, SB17 was recommended for approval by the EU’s Committee for Medicinal Products for Human Use in February 2024.  Samsung Bioepis also has a BLA for SB17 under review by the FDA, although Samsung cannot commercialise SB17 in the US until 22 February 2025 under a settlement and licence agreement with J&J.  If approved in the US and EU, SB17 will be commercialised by Sandoz pursuant to a deal entered into with Samsung Bioepis in September 2023.

Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

April 11, 2024

On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab)  biosimilar FYB201 in Canada and Switzerland.  Health Canada granted marketing authorization under the tradename RanoptoTM, and Swissmedic has approved FYB201 under the tradename Ranivisio®.

FYB201 was developed by Bioeq AG subject to the joint venture between Formycon AG and Polpharma Biologics Group BV.  In mid 2021, Bioeq entered an exclusive commercialisation agreement with Teva for FYB201 in Canada and Europe (among other regions).

April 11, 2024

On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for its ZYMFENTRA®. ZYMFENTRA® is the world’s first self-developed subcutaneous injection of infliximab for treating autoimmune diseases.  Celltrion claims to have exclusive rights to its subcutaneous formulation until the patent’s “expiration in 2038”.

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first US Approved subcutaneous formulation of infliximab (approved by the U.S. FDA in 2023).

April 10, 2024

Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader, Novo Nordisk. This extended collaboration, set to span five years, is targeting improving the manufacturing of Novo Nordisk’s medicines with a focus on chronic diseases including diabetes and obesity.

Ginkgo Bioworks, known for its expertise in cell programming and biosecurity, will bring its synthetic biology platform to optimize Novo Nordisk’s R&D pipeline for serious chronic diseases.

This news follows the 25 March 2024 announcement by Novo Nordisk of its acquisition of Cardior Pharmaceuticals for (up to) € 1.025B.

April 10, 2024

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Fresenius Kabi in respect of Dr Reddy’s proposed DRL_RI (rituximab), biosimilar to Genentech’s/Biogen’s Rituxan®.  The terms of the settlement between the parties have not been publicly disclosed.

The proceeding was commenced on 17 November 2023, following Dr Reddy’s submission of its aBLA to the FDA seeking approval for DRL_RI.  DRL_RI was to be commercialised by Fresenius in the US and by Dr Reddy’s in other jurisdictions.

Rituximab is an old molecule and was one of the first mAbs to become “biosimilar”, with the first rituximab approval in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020)Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

April 8, 2024

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report.  The quarterly report details average sales price information for US launched biosimilars and market share and price trends.

The Q2 2024 Report notes that as of April 2024, the FDA has approved 48 biosimilars, with three of those (Alvotech’s/Teva’s Simlandi® (Humira®, adalimumab), Sandoz’s Jubbonti®/Wyost® (Prolia®/Xgeva®, denosumab) and Fresenius Kabi’s Tyenne® (Actemra®, tocilizumab) approved in the last quarter.  38 of the 48 approved biosimilars have launched in the US.

Samsung Bioepis reports that, on average, biosimilars in the US have gained 53% market share within 3 years post initial launch.  As at Q4 2023, the adalimumab biosimilars share of the US adalimumab market was 4%, although this was up 2% compared with last quarter. The first biosimilar was launched in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the US market in July 2023.

April 8, 2024

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Xgeva®) received marketing approval in China.  MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab.  It is approved in China for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment.

Results of Mabwell’s Phase III trials were published in JAMA Oncology in February 2024 .  In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®.

April 5, 2024

On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer (NCT06348199).

Biocad initiated phase 1 clinical trials for its pembrolizumab biosimilar  BCD-201 in July 2022.  Sandoz anticipates commencing phase 1 clinical trials for its pembrolizumab biosimilar  in 2024.  Formycon, Xbrane, and Celltrion have each previously announced their development of pembrolizumab biosimilars.

April 5, 2024

On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is equivalent in efficacy, safety, tolerability and immunogenicity to Amgen’s Prolia®.  HLX14 will be indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

SHB announced the successful completion of its phase 1 clinical trials of HLX14 in January 2024.

In June 2022, SHB announced its licence agreement with Organon under which Organon received exclusive global commercialisation rights to HLX14, excluding China, Hong Kong, Macau and Taiwan.

April 4, 2024

On 4 April 2024, each of Teva Pharmaceuticals and Fresenius Kabi-owned mAbxience announced a strategic licensing agreement relating to an unnamed biosimilar which is already in development for the treatment of multiple oncology conditions.  The deal covers multiple markets, including the Europe and the United States.  MAbxience offers its biosimilar development expertise and manufacturing facilities in Spain and Argentina whilst Teva will oversee the regulatory processes and commercialisation.

April 3, 2024

The Korea Biomedical Review reported that, on 3 April 2024, the Korean Ministry of Food and Drug Safety approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for the treatment of nAMD and DME.

High Dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME).

April 3, 2024

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

  • Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
  • Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.

April 2, 2024

On 2 April 2024, Hangzhou Jiuyan Gene Engineering announced the acceptance of its Chinese application for JiyoutaiTM, biosimilar to Novo Nordisk’s Ozempic® (semaglutide), for type 2 diabetes.  This application is reportedly the first in PRC for a semaglutide biosimilar.

According to Novo’s 2023 annual report, patent protection in China for Ozempic expires in 2026.

April 2, 2024

On 2 April 2024, Korea Biomedical Review reported Samsung Bioepis’ Korean launch of Epysqli®, biosimilar to AstraZeneca’s Soliris® (eculizumab), with a 30% price reduction.  Soliris®, developed by Alexion Pharmaceuticals and marketed by AstraZeneca, is used for the treatment of rare conditions such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.  The annual cost for treatment with Soliris® is approximately 400 million won per patient.

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

March 31, 2024

The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under evaluation adding 11 new medicines which were accepted for review between February and March 2024.  Amongst others, the register shows:

In February:

  • MSD’s Keytruda® (pembrolizumab) was accepted for review for a new indication treating patients with locally advanced or metastatic urothelial carcinoma;
  • Amgen’s blinatumomab was accepted for review for the treatment of B-cell precursor acute lymphoblastic leukemia in the consolidation phase; and
  • Novo Nordisk’s Refixia® (nonacog beta pegol) was accepted for review for the treatment and prophylaxis of bleeding in patients with haemophilia B.

In March:

  • BMS’ nivolumab and Pfizer’s marstacimab were accepted for evaluation; and
  • MSD’s sotatercept (Australian brand name yet to be confirmed) was accepted for evaluation for the treatment of pulmonary arterial hypertension.

The TGA acceptance of MSD’s sotatercept comes after MSD’s WinrevairTM (sotatercept) was approved in the US by the FDA in March 2024.

March 28, 2024

On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg dose launched in January 2024 and a 40mg dose, first approved by the FDA in May 2023, launched last year.  All dosage forms are the high concentration formulation of adalimumab (100mg/mL).

Earlier this year, Celltrion applied to the FDA seeking interchangeable status for Yuflyma®.  Celltrion has previously said that it “tentatively expects” interchangeability designation to be granted in Q4 2024.

March 28, 2024

Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).  If approved, enfortumab vedotin with Keytruda® (pembrolizumab) would become the first combination treatment to offer an alternative to platinum-containing chemotherapy in China.

The European Medicines Agency (EMA) validated a Type II variation application for the same indication earlier this year.

March 28, 2024

Merck (MSD) announced that the European Commission approved Keytruda® (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC).  The announcement comes after positive results over several measures from the Phase 3 KEYNOTE-671 clinical trial.

The news follows US FDA approval for the same indication reported in 2023.

March 27, 2024

On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of  healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar to MSD’s Keytruda® (pembrolizumab).   Amicogen has reportedly completed the cell line development, and process development with Avantor.  Reportedly, Rophibio will determine market entry dates based on patent barriers and the competitive landscape.

March 27, 2024

On 27 March 2024, Biocon announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) approved its liraglutide in the UK, which is the first approved biosimilar to Novo Nordisk’s Victoza® (liraglutide).  Biocon’s liraglutide, a drug-device combination (6mg/ml solution for injection in pre-filled pen) used to treat Type 2 Diabetes, was filed and will be marketed in the UK by its European partner, Zentiva.

This follows the Indian launch of a liraglutide biosimilar, Glenmark’s Lirafit®, in January this year.

March 26, 2024

On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH).  FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which functions by rebalancing proliferative signals to regulate vascular cell proliferation in PAH.  The FDA approval was based on Phase 3 STELLAR trial results which showed 84% reduction in the occurrence of death or PAH clinical worsening events in comparison to placebo.

March 25, 2024

The Korea Biomedical Review reports that South Korean company, Sam Chun Dang Pharm Co Ltd (SCD), has entered an exclusive distribution agreement with an unnamed distributor to supply its Eylea® (aflibercept) biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland.  SCD attributes the deal to it being the first to apply for European Medicines Agency approval for an aflibercept biosimilar pre-filled syringe.

SCD’s biosimilar to Regeneron’s Eylea®, SCD411, was also the subject of an exclusive distribution agreement reported in November 2023, between SCD and an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland.  In North America, SCD has licensed SCD411 to Apotex for the Canadian market.

March 25, 2024

On 25 Mar 2024, Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for (up to) € 1.025B comprised of an initial payment and milestone payments.

Cardior Pharmaceuticals specialises in RNA-targeted therapies aimed at preventing, repairing, and reversing heart diseases.  Its lead compound, CDR132L, reportedly selectively blocks abnormal levels of miR-132.  Phase 1b trial results showed promising safety and tolerability along with promising cardiac functional improvements in heart failure patients.  As reported in Novo Nordisk’s press release, the ongoing phase 2 trials aim to benefit individuals with heart failure with reduced ejection fraction (HFrEF) who have previously experienced a heart attack.

The Novo Nordisk press release states that it plans to initiate a second phase 2 trial to investigate CDR132L in a chronic heart failure population with cardiac hypertrophy.

The acquisition is expected to be finalised in the second quarter of 2024, subject to regulatory approvals.

This news follows the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it acquired global contract development and manufacturing company Catalent for USD $16.5B, a deal which is expected to close in late 2024.

March 24, 2024

On 24 March 2024, the Korea Economic Daily (KED) reported Samsung Bioepis entered pre-clinical stage, with multiple undisclosed gene therapy candidates, for the treatment of rare diseases.

According to KED, Samsung Bioepis is committed to advancing drug development through the utilization of antibody-drug conjugates (ADCs), and by next year it intends to submit an investigational new drug (IND) application to initiate a phase 1 clinical trial, with a focus on rare diseases such as liver and metabolic disorders.

March 22, 2024

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative colitis.  Samsung Bioepis informed the Court that it has applied for regulatory approval of its biosimilar referencing Stelara® and is expecting PBS (reimbursement) approval in July/August 2025.   The Court has provisionally scheduled a trial for 18 – 22 November 2024.

March 22, 2024

On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.

Once-weekly Awiqli® dosing demonstrated superior blood sugar reduction and time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients. For those not previously treated with insulin, rates of clinically significant or severe hypoglycemia were low. In type 1 diabetes patients, Awiqli® was non-inferior in reducing HbA1c but showed a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec. The drug appeared safe and well-tolerated across the program.

Novo Nordisk anticipates final marketing authorisation from the European Commission in the coming months.

This news comes soon after Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events.

This news also follows on the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.

March 22, 2024

On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting.  CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:

Other positive opinions adopted by CHMP include:

An indication extension was recommended for UCB’s previously EU-approved Bimzelx® (bimekizumab) for the treatment of hidradenitis suppurativa.

March 22, 2024

On 22 March 2024, Korea Biomedical Review reported Geo-Young, South Korea’s largest pharmaceutical distributor,  signing a third-party logistics (3PL) contract with Samsung Bioepis for the distribution of biosimilar medicines within South Korea. This is the first business agreement between the two companies in which Geo-Young will carry out the entire distribution process from warehousing to storage and shipping.  Geo-Young will distribute Samsung Bioepis biosimilar products to general hospitals nationwide.

March 20, 2024

On 20 March, 2024, BMS announced that its CAR-T cell immunotherapy Abecma ® (idecabtagene vicleucel) was granted an extension of its therapeutic indication, now being approved for treatment of relapsed and refractory multiple myeloma (R/R MM) in patients undergoing their third line of treatment (the indication was previously limited to fourth line treatment). The approval of the amended indication by European Commission follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP). The approval positions Abecma® as the first CAR-T cell therapy approved in the European Union for adult patients with R/R MM undergoing their third line of treatment.

March 20, 2024

On 20 March 2024, Alvotech announced its full year financial results for 2023, highlighting increased product revenue and Alvotech’s acceptance of an offer from a group of investors for the sale of approximately 10 million ordinary shares in an Alvotech subsidiary for an approximate gross value of US$166 million, the net proceeds to be used for working capital.  (Alvotech subsequently announced on 22 March 2024 the issue of 13,000,000 new ordinary shares to that subsidiary).

The announcement also noted recent pipeline highlights including US approval of AVT02 (marketed as Simlandi®), biosimilar to Humira® (adalimumab), addressing an earlier CRL for the Reykjavik facility, approval of AVT04, biosimilar to Stelara® (ustekinumab) in Canada and Europe, and positive top-line results from studies on AVT05, biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, biosimilar to Eyelea® (aflibercept) and AVT03, biosimilar to Prolia® and Xgeva® (denosumab).  On the associated webcast Alvotech responded to a question by noting it is preparing for potential manufacturing/product changes to Keytruda®, reference product for AVT33 (pembrolizumab).

March 20, 2024

On 20 March 2024, China Daily reported that Novo Nordisk has announced investing USD 560 million in its Chinese facility (in Tianjin which was first opened in 1994) as part of its expansion project to further increase manufacturing capability to support the localization of more innovative medicines. The project also encompasses the development of a state-of-the-art filling facility equipped with isolator technology. Novo Nordisk has already started development and the expansion is estimated to be completed in 2027.

March 20, 2024

On 20 March 2024, Lonza announced it has entered an agreement to acquire Genentech’s large-scale biologics manufacturing site in Vacaville, California (US) from Roche for US$1.2 Billion.

The facility has a total capacity of around 330,000 liters which is reported to be one of the largest biologics manufacturing sites in the world by volume.

Under the agreement, approximately 750 of Genentech’s employees at the facility will be offered employment by Lonza. Lonza plans to invest approximately US$556 million to upgrade the facility and enhance its capabilities for commercial contract manufacturing.

March 19, 2024

On 19 March 2024, Dr. Reddy’s announced the launch of its Versavo® (bevacizumab) in the UK. Versavo® is a biosimilar to Genentech’s Avastin®(bevacizumab) and is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer.   Versavo® is Dr. Reddy’s first biosimilar product to be approved and launched in the UK and is supplied in 100mg and 400mg single use vials.

Versavo® was launched in India just under 5 years earlier, in August 2019.   The first bevacizumab biosimilar was approved in the UK in January 2018  resulting in Dr Reddy’s launching its biosimilar more than 6 years after the first approved biosimilar.

March 18, 2024

On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada.  The announcements did not disclose the permitted launch dates for FYB202 in those regions.

In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”.

March 18, 2024

On 18 March 2024, Bio-Thera Solutions announced that it is partnering with SteinCares to commercialise two unnamed biosimilars in LATAM.  SteinCares will have exclusive right to distribute and market Bio-Thera’s two biosimilar pharmaceuticals in LATAM and Bio-Thera is responsible for and regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region.  Bio-Thera is responsible for commercial supply out of its manufacturing facilities in Guangzhou, China.

March 18, 2024

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first subcutaneous formulation of infliximab approved by the U.S. FDA in 2023.  Zymfentra is approved for maintenance therapy in adults with active ulcerative colitis or Crohn’s disease following an induction treatment regimen with an intravenous infliximab product.


Celltrion emphasised that the sub-cutaneous administration method offers patients greater flexibility in managing their disease. According to Celltrion, ZYMFENTRA™ is patent protected until 2037 for the formulation and 2040 for the method of treatment.

March 15, 2024

On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered at the November 2023 PBAC meeting. Decisions included:

March 15, 2024

On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®.  The trials were conducted on 165 healthy adults in Australia and New Zealand.

CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients.  CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.

Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development.  Celltrion submitted an A-BLA in the US  earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.

March 14, 2024

On 14 March 2024, AstraZeneca announced that it has entered into an agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.  Amoylt’s portfolio notably includes eneboparatide (AZP-3601) currently a phase III investigational therapeutic peptide for the hypoparathyroidism.  The deal consists of $800m upfront and then $250m contingent on achieving specified regulatory milestones.

March 13, 2024

On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales.  Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab)  in the US and entering an agreement to commercialise Samsung Bioepis’ SB17 (biosimilar to Janssen Biotech’s Stelara®) in the US, Canada, EEA, Switzerland, and UK.

In March 2024, Sandoz announced completion of its acquisition of Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.

March 12, 2024

On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit challenging findings of the Patent Trial and Appeal Board (PTAB) that claims of two of its patents are invalid. The Regeneron patents at issue are 10,130,681 and 10,888,601  relating to methods of treatment using Eylea® (aflibercept).

As previously reported, the PTAB findings were made in inter partes review proceedings IPR2022-01225 and IPR2022-01226, commenced by Mylan in July 2022.  PTAB held that all challenged claims of the two patents were anticipated by a prior art journal publication.

March 11, 2024

The Biden Administration proposes to amend s352 of the Public Health Service Act so that all approved biosimilars are deemed to be interchangeable with their respective reference drug.

On 11 March 2024, the Biden Administration released its 2025 Budget Proposal in which it recommends allowing biosimilar substitution without FDA’s determination of interchangeability.  According to U.S. Department of Health & Human Services (HHS):

The statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding, including among patients and healthcare providers, about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars

March 11, 2024

Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab).  Celltrion’s application seeks approval for all Xolair® indications, as well as interchangeability status.

Celltrion submitted applications for CT-P39 in Europe in April 2023, Canada in December 2023 and Korea in June 2023.   Celltrion’s is the first reported regulatory submission for omalizumab biosimilars in these jurisdictions.   CuraTeQ Biologics (a subsidiary of Aurobindo), Alvotech/Kashiv Biosciences, Teva, Synermore, Glenmark and Sorrento have also been reported to be developing omalizumab biosimilars.

March 11, 2024

On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes.

FYB201 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. FYB201 has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli® by Coherus) and the EU (in August 2022, marketed as Ranivisio® by Formycon). In January 20204, Sandoz announced that it had signed an agreement to acquire Coherus’ Cimerli® for US$170M.

March 11, 2024

On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.  The product is currently approved in the US to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis.

March 11, 2024

On 11 March 2024, Merck (MSD) announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M with the aim of augmenting and diversifying their oncology pipeline.  Harpoon’s lead candidate is MK-6070 and its safety, tolerability and pharmacokinetics profile is currently being evaluated in a Phase 1/2 clinical trial (NCT04471727) in patients with advanced cancers.

March 11, 2024

On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based chemotherapy.  Keytruda® is the first immuno-oncology drug approved in Korea for the treatment of all types of HER2-positive and negative metastatic gastric cancer.

March 11, 2024

On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024.  The approval was based on Phase 3 randomized trials in patients aged 8-17.  The results, published in the Journal of the American Medical Association Pediatrics, show that those who received alirocumab every four weeks had 31% lower LDL-C than the placebo group at 24 weeks.

In 2014, Amgen commenced litigation against Sanofi, alleging that Sanofi’s and Regeneron’s Praluent® infringed genus claims of Amgen’s patents relating to Repatha® (evolocumab).  In May 2023, the US Supreme Court published its decision affirming a ruling of the Federal Circuit Court that Amgen’s genus claims were invalid for lack of enablement.

March 10, 2024

On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study.  This is the first-of-its-kind study of lebrikizumab specifically designed to treat people with moderate-to-severe atopic dermatitis. This is also commonly known as eczema.  The results show that two-thirds of the patients with atopic dermatitis experienced improvements by taking lebrikizumab.  The study lasted for 16 weeks and evaluated a total of 50 patients.

March 9, 2024

On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.   

For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023.  Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023.  Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018. 

For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks.  These results were presented at ECCO last month. 

SB5/Hadlima™ is commercialised in the US by Organon.  SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  inked in September 2023.   

March 8, 2024

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD).  The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%.  It is the first US approved therapy to assist with weight management and reduce cardiovascular risk. 

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024. 

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic®  (semaglutide) for kidney outcomes.

This news follows the announcement on 5 February 2024 by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.  

March 8, 2024

Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).  The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials. 

High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME) and diabetic retinopathy, the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME). 

March 6, 2024

On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medical Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.  The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen. 

This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination 

March 6, 2024

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its 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) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

March 5, 2024

On 5 March 2024, a study published in Modern Rheumatology found that LG Chem’s LBEC0101, the biosimilar of etanercept, matches up to the reference product in terms of effectiveness and safety in the real-world treatment of rheumatoid arthritis. This evidence was gathered from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients treated between 2015 and 2021. The study reports that patients who switched from the reference product to LBEC0101 did not experience any significant differences in their treatment outcomes.

March 5, 2024

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

March 5, 2024

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022.   

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

March 5, 2024

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

March 5, 2024

Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.  

March 5, 2024

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

March 5, 2024

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatmentBetween 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

March 4, 2024

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

March 4, 2024

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

March 4, 2024

Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025.  The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda involving six patents relating to aflibercept.  The settlement does not appear to have resolved disputes beyond Canada, there being no impact to the ongoing US aflibercept dispute between Biocon and Regeneron.   

Yesafili® was granted tentative approval by Health Canada in March 2023, subject to resolution of patent issues.  Yesafili® was approved in the UK in November 2023 and in EU in September 2023. 

March 4, 2024

On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite instability-high (MSI-H).    These four IPRs are IPR2024-00622 (against US10,934,356), IPR2024-00623 (against US11,325,974), IPR2024-00624 (against US11,325,975), and IPR2024-00625 (against US11,339,219).  Each IPR is based on anticipation and obviousness.  The petitions have not yet been instituted by the USPTO.

In November 2022 Merck filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel in relation to the same four patents.   The trial has not yet been scheduled.

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 21, 2024

On 21 February 2024, the US Patent Trial and Appeal Board (PTAB) entered an adverse judgment against Regeneron in inter partes review proceeding IPR2023-00462.  The IPR was commenced by Celltrion and Samsung Bioepis in relation to Regeneron’s aflibercept formulation patent no. 10,464,992 (‘992 Patent) and was instituted on 11 December 2023.  The adverse judgment was entered after Regeneron filed a statutory disclaimer with the US Patent Office on 17 January 2024 relinquishing its rights to all claims of the ‘992 Patent “for the sake of efficiency, as the patent is no longer needed”.

The ‘992 Patent is one of numerous US Eylea® (aflibercept) patents asserted by Regeneron against Samsung Bioepis in infringement proceedings commenced in November 2023 and December 2023 in the United States District Court for the Northern District of West Virginia.  Patent litigation asserting the ‘992 Patent was also brought by Regeneron against Formycon and Celltrion in November 2023 and Amgen in January 2024.

In August 2022, Regeneron sued Mylan and Biocon for infringement of 24 patents relating to Eylea®, including the ‘992 Patent.  Regeneron subsequently reduced its asserted patents to three for a “first wave trial”, excluding the ‘992 Patent.  Judgment was issued in that matter on 27 December 2023, with detailed reasons published on 31 January 2024.

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) 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

On 19 January 2024, an Alvotech-sponsored study, published in the Sage Journal, concluded on the basis of a “totality of evidence approach” that there was no clinically meaningful difference between Alvotech’s AVT02 (adalimumab biosimilar) and AbbVie’s Humira® (adalimumab). The study found that there were minor differences in a few physiochemical attributes, however, that did not impact the in vitro biologic activity and therefore this difference was ruled out and not considered clinically relevant.

On 23 February 2024, FDA approved Alvotech’s SIMLANDI® (AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira® after which Alvotech’s U.S listed shares rose more than 12% to $18 in pre-market trading.

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

On 18 January 2024, a phase 3 study, published in The Lancet Rheumatology, sponsored by Bio-Thera and Biogen concluded that BAT1806 (tocilizumab biosimilar) was equivalent in efficacy, safety, immunogenicity, and pharmacokinetic in comparison to Roche’s RoActemra®(tocilizumab).  The study was randomized, double-blinded, multicenter, and multinational.  It consisted of a 24-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), and an extra 4-week follow-up period.  In total there were 621 participants out of which 309 were assigned to the reference tocilizumab group and the rest 312 were assigned to the BAT1806 group.

On 16 January 2023, Bio-Thera Solutions announced that China’s NMPA approved its BAT1806 for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

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 degeneratio