BioBlast w/e 24 Feb 23: Abbvie in hot water over Humira® pricing, Celltrion’s Yuflyma® delays explained, Merck/Moderna mRNA vaccine/ Keytruda treatment, French Court overturns Novartis/Roche €444M cartel fine, Amgen’s Amjevita® savings, Genetech new biologics facility, Regeneron new aflibercept product, Amgen’s Bekemv® eculizumab

by , , | Feb 27, 2023

Significant biosimilar activities this week include:

22 February 2023 | EU | AbbVie sued by Dutch group over Humira® pricing 

The Financial Times has reported that the Dutch Pharmaceutical Accountability Foundation (PAF), a public interest group, is suing Abbvie for allegedly overcharging citizens for Humira® (adalimumab) in Holland. PAF is arguing that the pricing of the drug is in breach of human rights.  AbbVie has rejected the allegations.

24 February 2023 | US | Delays for Celltrion’s Yuflyma® (adalimumab) biosimilar in US 

The Korea Biomedical Review has reported that Celltrion has explained to shareholders the delay in obtaining US approval for its Humira® adalimumab biosimilar Yuflyma®. Despite obtaining EMA approval in December 2020, Celltrion confirmed that FDA took issue with Celltrion’s overseas and end-product manufacturing plants. Celltrion has rectified the problems and the FDA will complete a final review by May 2023. We have previously reported on Yuflyma®’s progress and approvals including its EU approval in December 2020, in CA on 24 December 2021 and in AU on 28 February 2022.   Celltrion is licensed to supply Yuflyma® in the US from July 2023 pursuant to its settlement with AbbVie.

January 2023 | US | Limited cost savings expected from Amgen’s Amjevita® (adalimumab) US launch 

Reuters reported that it expects only limited cost savings to result from Amgen’s launch of Amjevita® (biosimilar to AbbVie’s Humira® adalimumab) in the US in January this year.  Reuters reported that while Amgen launched Amjevita at two price points (one with a 5% discount to Humira, and one with a 55% discount to Humira), the more heavily discounted product is not expected to be as widely used.

Costs may ease later this year with the launch of biosimilars developed by Alvotech (1 July 2023), Celltrion (July 2023 – but Celltrion’s launch may be delayed as reported above), Mylan/Viatris (31 July 2023) Sandoz (30 September 2023), Momenta (20 November 2023) Pfizer (20 November 2023), Fresenius Kabi (30 September 2023), Samsung Bioepis/Merck (30 June 2023), Coherus (1 July 2023) and Boehringer Ingelheim (1 July 2023).

17 November 2022 | CN | Sintilimab and bevacizumab biosimilar combination may improve quality of life compared with lenvatinib alone

A Chinese study by Innovent Biologics, Inc. has demonstrated that the combination therapy of sintilimab and bevacizumab biosimilar provided better quality of life for the treatment of hepatocellular carcinoma, albeit at a higher cost ($33,102 vs $21,037 (2021 USD)), compared with lenvatinib.

23 February 2023 | US | FDA accepts BLA for aflibercept 8mg with priority review 

Regeneron announced that the FDA has accepted for priority review its BLA for aflibercept 8mg for treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.  The BLA was supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks.  The FDA target action date is 27 June 2023. Aflibercept 8mg is being jointly developed by Regeneron and Bayer A.G.

22 February 2023 | Alteogen susidiary Altos Biologics completes enrolment in Ph III biosimilar aflibercept trials 

South Korea’s Alteogen announced that its subsidiary Altos Biologics has completed patient enrolment in its Ph III trials of ALT-L9 aflibercept (biosimilar to Regeneron’s Eylea®) in patients with neovascular  age-related macular degeneration.  Alteogen reported that it plans to submit the BLA in early 2024, with a European launch anticipated in the first half of 2025.

23 February 2023 | EU | EMA CHMP give positive opinion to Amgen’s Bekemv® eculizumab biosimilar 

The EMA CHMP has recommended a grant of market authorization for Bekemv®, Amgen’s eculizumab biosimilar to Alexion’s Soliris® (eculizumab). Bekemv is indicated for the treatment of paroxysmal nocturnal haemoglobinuria in adults and children.

22 February 2023 | US | Eli Lily announce annual financial results 

Eli Lily has published its annual financial report, noting that the there was a 12% increase in revenue in the US, and 13% increase outside of the US, from sales of Taltz® ixekizumab. The annual report discloses that Eli Lily derived more than US$2.48 billion from the supply of Taltz® worldwide.

22 February 2023 | US | FDA grants breakthrough therapy designation for Moderna and Merck mRNA and Keytruda® combination vaccine 

Merck (known as MSD outside of the United States and Canada) and Moderna announced a new investigational mRNA cancer vaccine mRNA-4157/V940 combined with Keytruda® (pembrolizumab) has been granted Breakthrough Therapy Designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. The designation will result in expedition of the FDA’s the  review of the combination treatment. According to the release, the companies will initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumor types (including non-small cell lung cancer). Merck and Moderna exercised the option to jointly develop the treatment in October 2022.

16 February 2023 | EU | French court overturns €444m Novartis/Roche antitrust fine regarding Lucentis® (ranibizumab) 

The Paris Court of Appeal (Cour d’Appel de Paris) has overturned the anti-trust fines implemented by Autorité de la Concurrence, France’s competition commission in 2020. The French competition commission claimed that Novartis and Roche abused their dominant market position to preserve the price of Lucentis® (ranibizumab) by “colluding in obstructive behavior” and spreading “alarmist” and “misleading” statements about the risks associated with a cheaper drug Avastin® (bevacizumab). However, the Appeal Court overturned the decision, finding no cartel conduct.

Novartis says that it “strongly contested these allegations from the outset and firmly believes the company has acted appropriately and in compliance with competition law and the interests of patients at all times”.

13 February 2023 | US | Fresenius Kabi study demonstrates bioequivalence for tocilizumab biosimilar 

A new Fresenius Kabi study published in the Expert Review of Clinical Immunity has confirmed pharmacokinetic bioequivalence between a tocilizumab biosimilar and a US-licensed tocilizumab (Actemra®). The authors also found that the safety profiles were similar. Tocilizumab is prescribed for autoimmune conditions including rheumatoid arthritis.

02 February 2023 | US | Genentech investing $450M to expand Oceanside facility (California, USA) 

Roche’s Genentech is investing US$450M in expanding its biologics capabilities at Oceanside California.  Approximately US$280M will go toward building a new biologics manufacturing facility that will begin operations in 2025. The new facility will produce protein-based medicines and antibodies, and will have capacity to manufacture small batches of drugs including personalised medicines and treatments for patients with rare diseases.

02 February 2023 | Fresenius Kabi and Formycon AG announce ustekinumab deal 

Fresenius Kabi announced that it has entered into a global license agreement with Formycon AG for the commercialisation of FYB202 (biosimilar to Stelara® ustekinumab). Under the agreement, Fresenius Kabi will gain semi-exclusive commercialisation rights to FYB202 in key global markets, including Germany, the MENA region and Latin America, in exchange for upfront and milestone payments contingent on the successful achievement of certain regulatory events, with post-commercialisation value to be shared equally. FYB202 is currently in advanced clinical stage.

22 February 2023 | EU | European Commission approves AstraZeneca’s durvalumab and tremelimumab immunotherapy combination 

AstraZeneca has announced that its Imfinzi® (durvalumab) and Imjudo® (tremelimumab) immunotherapy combination has been approved in the EU for first-line treatment of advanced liver and lung cancers. The approval follows recommendations by the EMA human medicines committee in December 2022 based on positive results from their POSEIDON and HIMALAYA Phase III trials.

BMS has brought patent infringement proceedings against AstraZeneca for its Imfinzi® product, with a jury trial set down for April 2024.

26 February 2023 | US | New study demonstrates dupilumab decreases inflammatory biomarker 

The phase III trial LIBERTY-EoE-TREET examined eosinophilic esophagitis patients treated with duplimab. The authors found that patients had improved histologic, symptomatic, and endoscopic results and the treatment was well tolerated. One of the authors Professor Evan Dellon presented a subanalysis of the data at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, Texas. Professor Dellon said in an interview that his research “suggests that the medication is biologically active and working on these mechanisms, or we think it would work.”

We have previously reported on the use of dipilumab for atopic dermatitis.

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