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Biosimilars Deals 2021

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.

Samsung Bioepis Commences Phase 3 Trials for Keytruda® Biosimilar

Apr 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.

Shanghai Henlius’ Ph 3 success for Prolia® biosimilar HLX14 (denosumab)

Apr 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.

Teva and mAbxience Global Licensing Deal for Oncology Biosimilar Candidate

Apr 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.

Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Korea

Apr 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).

Sandoz’s High Concentration Adalimumab Biosimilar on AU July PBAC Agenda

Apr 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.

Samsung Bioepis Launches Soliris® (eculizumab) Biosimilar in Korea with 30% Price Drop

Apr 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.

Pearce IP BioBlast w/e 29 March 2024

Apr 2, 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.

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.

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.

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.

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.

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.

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”

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Restored, but only just! Quirks of New Zealand law almost stump Avalyn Pharma’s quest for patent protection

Apr 1, 2024

Avalyn Pharma Inc. [2024] NZIPOPAT4

 

Date:

Court:

Adjudicator:

 

14 February 2024

Intellectual Property Office of New Zealand

Warren Coles, Assistant Commissioner of Patents

The sequence of events set out in the decision in Avalyn Pharma, Inc. [2024] NZIPOPAT 4 (Avalyn) provides a good example of the importance of understanding the nuances of patent practice in New Zealand.  In particular, New Zealand law provides staggered deadlines for responding to an examination report.  The law also provides a finite window of opportunity for seeking patent protection under a divisional application, which can abruptly compress depending on progress made during prosecution.  A clear understanding of deadlines is therefore critical when developing a New Zealand-specific patenting strategy.

Prosecution and divisional practice in New Zealand

Deadlines during New Zealand patent prosecution can be complex.  Once a standard patent application is filed in New Zealand, examination must be requested on or before a deadline of 5 years after the effective filing date.  For a PCT application entering national phase in New Zealand, the deadline for requesting examination is 5 years after the international filing date.  Additionally, the issuance of a first examination report sets a 12 month, non-extendible acceptance deadline.  However, the date of the first report also sets in place a 6 month deadline to file a response, which is extendible by 1 month on written request.  For a subsequent examination report, the response deadline is 3 months from the date of the examination report, extendible by 1 month on written request.

There are also several overlapping criteria for validly seeking protection under a divisional patent application in New Zealand.  These include, but are not limited to the following:

  • A divisional application must be filed while the parent is pending and before the parent application is accepted.
  • All divisional applications must be filed within 5 years from the effective filing date of the parent.
  • A request for examination of any and all divisional applications must be made on or before the 5 year deadline set in respect of the parent.

The facts of Avalyn

Avalyn Pharma, Inc.’s New Zealand Application No. 717528 (NZ 717528) is a national phase application derived from PCT Application No. PCT/US2014/049294.  In this case, the attorney responsible for directing global patent prosecution was based in the US, and the attorney handling the New Zealand prosecution was a Trans-Tasman patent attorney based in Australia.[1]

A request for examination for NZ 717528 was filed on 31 July 2019, which was the 5 year deadline as calculated from the effective filing date.  A divisional application was not filed at that time.  A first examination report issued with a response deadline of 17 December 2021, extendible to 17 January 2021.  Due to a series of docketing errors in the US, the examination response deadline was not met and NZ 717528 became abandoned.  A request for extension of time to respond to the examination report was made but rejected by the New Zealand Patent Office.

A request for restoration of NZ 717528 was then filed with statutory declarations from both the US and Australian attorneys with supporting evidence.  The declarations indicated that the US patent attorney did not have a clear understanding of the non-extendible 5 year deadline to file a divisional application in New Zealand.  This misunderstanding was compounded when the Australian attorney erroneously reported that a divisional application could be filed after the 5 year deadline, although this error was subsequently corrected.  In any event, this lack of understanding and miscommunication resulted in the response deadline being removed from the US attorney’s records.  The evidence indicated that the US attorney relied on being able to file a divisional application while the parent was pending to maintain rights.

After consideration of all the evidence, the Examiner determined that it was Avalyn’s intention to abandon NZ 717528 in favour of a divisional application, and so NZ 717528 should not be restored.  Primarily, the determination of intent was based on the US attorney’s records which effectively marked NZ 717528 as abandoned while adding the divisional application.  The Examiner determined that a misunderstanding of the deadlines did not constitute an unintentional failure as required for restoration.

This decision was reversed by the Assistant Commissioner after a hearing. The Assistant Commissioner found that there was no overall intent to abandon the family, and that NZ 717528 should be restored.  He focused on the intent of Avalyn instead of the US or Australian attorney.

Key to the Assistant Commissioner’s decision was evidence from Avalyn that its global patent strategy required filing of divisional applications, and that it had never instructed abandonment of any application in the global patent family, including this one.  Noting Avalyn’s lack of intent to abandon NZ 717528, the Assistant Commissioner was satisfied that the request for restoration should be granted providing a further 1 month to achieve acceptance.

Key takeaways

This case highlights the unique aspects of New Zealand patent practice, emphasising the importance of having a clear divisional strategy and corresponding accurate deadline monitoring systems, and that there can be extensive steps required to achieve restoration where a patent application is inadvertently abandoned.

As an aside, while not explored in the decision, the fact that a 1 month extension was granted to pursue acceptance of NZ 717528 still would not provide Avalyn with the opportunity to validly file a divisional application.  A separate extension of time request is required to file a divisional application, and while such extensions are difficult to obtain, Avalyn may be in a position to obtain an extension based on this decision.

[1] Under a bilateral agreement between Australia and New Zealand, Trans-Tasman patent attorneys are able to practise before both the Australian and New Zealand patent offices.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Julie Ballance

Julie Ballance

Special Counsel (NZ), Patent Attorney, Lawyer & Notary

Julie is a senior Trans-Tasman patent attorney, and a New Zealand registered lawyer and notary public with more than 30 years’ experience across a range of technology areas and a first class honours degree in chemistry. Julie is internationally renowned for her considerable patent/trade mark/designs/legal prowess, including being ranked in IAM Patent 1000.

Chris Vindurampulle PhD

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand.  He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work.  Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

Transparency Measures Glitch Resolved: AU’s TGA publishes “catch up” list for medicines accepted between February and March 2024

Mar 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.

Celltrion Launches US Pediatric High Concentration Adalimumab Biosimilar

Mar 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.

China National Medical Products Administration (NMPA) Accepts sBLA for enfortumab vedotin and Keytruda® (pembrolizumab) Combination Treatment of Urothelial Cancer

Mar 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.

Approval Alert: European Commission Approves MSD’s Keytruda® (pembrolizumab) Plus Chemotherapy for Resectable Non-Small Cell Lung Cancer (NSCLC)

Mar 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.

Rophibio Enters Development Agreement with Avantor for Keytruda® (pembrolizumab) Biosimilar

Mar 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.

Approval Alert: Biocon Receives First UK Approval of Liraglutide Biosimilar

Mar 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.

Approval Alert: MSD’s WINREVAIR™ (sotatercept-csrk) Granted FDA Approval for Treating Adults with PAH

Mar 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.

ABC Law Report Podcast features Pearce IP Founder Naomi Pearce

Mar 26, 2024

The perils of prioritising commercial strategies over patenting strategies

Pearce IP’s Founder Naomi Pearce discusses this topic on prime time radio with ABC Law Report Host Damian Carrick, in light of the recent decision of the Federal Court in Allied Pumps Pty Ltd v LAA Industries Pty Ltd handed down in late November last year.

As Naomi said: “The lesson for inventors is make sure you have your IP strategy leading your commercial strategy. If you do it the other way around, beware – you may well result in your own conduct resulting that you can’t get valuable protection for your invention.”

Listen to Naomi here (discussion starts at [15:18]).

Pearce IP BioBlast w/e 22 March 2024

Mar 25, 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 at least 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.

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.

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.

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.

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.

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).

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.

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.

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.

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”.

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.

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.

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.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Sam Chun Dang to Distribute Eylea® (aflibercept) Biosimilar in Nine European Countries

Mar 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.

Novo Nordisk to Acquire Cardior in €1.025B Acquisition

Mar 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.

Samsung Bioepis Initiates Novel Drug Development for Rare Diseases

Mar 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.

Samsung Bioepis Seeks to Revoke Janssen’s Stelara® (ustekinumab) Patents in Australian Court

Mar 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 at least 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.

Novo Nordisk’s Awiqli® (insulin) Recommended for EU Approval

Mar 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.

CHMP Positive Opinion for Sandoz’s Denosumab and Celltrion’s Omalizumab Biosimilars

Mar 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.

Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | BMS/Merck

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

natalizumab | Tysabri® | Biogen/Elan

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | Merck

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

View latest BioBlast® updates

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BioBlast® Editor and Contributing Author

Naomi Pearce, Chantal Savage & Faran Shahzad

Naomi Pearce, Chantal Savage & Faran Shahzad

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