Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency (EMA) accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

FDA to Review Aflibercept Biosimilar Applications

Formycon and Celltrion shared that they have submitted a biologics license application for their respective aflibercept biosimilar candidates referencing Eylea, according to Big Molecule Watch.

Eylea is a vascular endothelial growth factor receptor inhibitor used to treat several ophthalmic conditions, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The companies represent the second and third biosimilar developers to announce submissions of BLAs for aflibercept biosimilars, following Viatris’ submission in October 2021.

Formycon’s application regarded FYB203, which was codeveloped by Formycon and its licensing partner, Klinge Biopharma. In January 2023, Coherus Biosciences announced that it could acquire the exclusive commercialization rights for FYB203 from Klinge. The phase 3 data submitted with the application assessed the biosimilar in patients with nAMD.

Celltrion’s product, CT-P42, is also under review in the European Union and other “major economies are forthcoming.” The data submitted within the application were from a phase 3 study evaluating the safety and efficacy of CT-P42 in patients with DME.

EMA Accepts Application for Stelara Biosimilar

The EMA accepted a marketing authorization application for Dong-A ST’s biosimilar referencing Stelara (ustekinumab), according to Financial Post.

The submission was based on results from an comparative analytical study assessing clinical outcomes associated with the biosimilar, DMB-3115, vs the US- and EU-sourced reference product. The submission also included results from a phase 3 multiregional clinical trial assessing the products in patients with plaque psoriasis. The primary end point was the rate of change in the Psoriasis Area and Severity Index. The results confirmed the biosimilarity of the biosimilar and reference products.

Stelara accumulated $17.77 billion in 2022 and is regarded as one of the best-selling biologics in the world.

Dong-A Socio Holdings and Meiji Seika Pharma began joint development on the biosimilar in 2013, and the rights for the research and development as well as the commercialization of the product were transferred to Dong-A ST in July 2020. The company has been working with Meiji Seika Pharma ever since to develop the drug.

Roche Sues Biogen Over Actemra Biosimilar

Roche and 2 of its subsidies filed suit against Biogen, accusing the company of infringing several of Roche’s patents regarding its rheumatoid arthritis drug Actemra (tocilizumab) when developing a tocilizumab biosimilar.

Roche along with Genentech and Chugai Pharmaceuticals alleged that Biogen’s biosimilar would infringe patents related to the manufacturing and use of Actemra, according to Reuters. Roche claimed that Biogen failed to provide detailed information during the biosimilar approval process that was necessary to determine whether the company infringed on Roche’s manufacturing patents.

A representative of Biogen declined to comment on the legal complaint, citing pending litigation. A spokesperson for Roche also declined to discuss the case but said that the company recognized the importance of biosimilar competition in ensuring the financial sustainability of health care systems and encouraging innovation within the biologics market.

Actemra was approved by the FDA in 2010 for the treatment of rheumatoid arthritis. It has since been approved for the treatment of hospitalized patients with COVID-19.