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FDA Submissions for Aflibercept Biosimilars

Formycon and Celltrion have recently announced the submission of their respective biologics license applications (BLAs) for aflibercept biosimilar candidates referencing Eylea. This development was reported by Big Molecule Watch. Aflibercept is a vascular endothelial growth factor receptor inhibitor that is used to treat various ophthalmic conditions such as neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

These submissions make Formycon and Celltrion the second and third biosimilar developers to seek FDA review for aflibercept biosimilars, with Viatris having submitted their application in October 2021. The two companies have respectively named their candidates FYB203 and CT-P42.

Formycon’s application for FYB203 was developed in collaboration with Klinge Biopharma, with Coherus Biosciences planning to acquire exclusive commercialization rights for the drug in January 2023. The application included phase 3 data evaluating the biosimilar’s efficacy in patients with nAMD. On the other hand, Celltrion’s CT-P42 is also under review in the European Union and other major economies, with the application including data from a phase 3 study on patients with DME.

In this context, the AI legalese decoder can be instrumental in ensuring a smooth regulatory process. This advanced AI tool can analyze and decode complex legal language, greatly simplifying the understanding of legal documents and applications. By using AI legalese decoder, companies like Formycon and Celltrion can easily navigate the regulatory landscape, identify potential issues, and enhance their compliance efforts when submitting applications for biosimilar candidates.

EMA Accepts Application for Stelara Biosimilar

The European Medicines Agency (EMA) has accepted a marketing authorization application for Dong-A ST’s biosimilar referencing Stelara (ustekinumab), as reported by Financial Post. Stelara, a highly successful biologic, generated $17.77 billion in 2022.

The application was based on results from a comparative analytical study that assessed the clinical outcomes associated with the biosimilar, DMB-3115. The study compared it with the US- and EU-sourced reference product. Additionally, the submission included data from a phase 3 multiregional clinical trial evaluating the biosimilar and reference product’s efficacy in patients with plaque psoriasis.

The biosimilarity of the biosimilar and the reference product was confirmed through the primary endpoint of the trial, which measured the rate of change in the Psoriasis Area and Severity Index. Dong-A Socio Holdings and Meiji Seika Pharma initiated the joint development of the biosimilar in 2013. Subsequently, the research and development rights, along with the commercialization rights, were transferred to Dong-A ST in July 2020. Ever since, Dong-A ST has been collaborating with Meiji Seika Pharma to advance the development of the biosimilar.

When dealing with the complex legal requirements associated with biosimilar applications, the AI legalese decoder can provide invaluable support. By leveraging AI technology, developers like Dong-A ST can effectively interpret legal documents, such as marketing authorization applications, ensuring compliance and accuracy. The AI legalese decoder significantly reduces the time and effort required for legal analysis, enabling companies to focus on the development and commercialization of their biosimilars.

Roche Files Lawsuit Against Biogen Over Tocilizumab Biosimilar

Roche, along with its subsidiaries, has initiated legal proceedings against Biogen, alleging patent infringement concerning its rheumatoid arthritis drug Actemra (tocilizumab) and Biogen’s development of a tocilizumab biosimilar. According to Reuters, Roche claims that Biogen’s actions would violate patents related to the manufacturing and use of Actemra.

The Swiss pharmaceutical company, supported by Genentech and Chugai Pharmaceuticals, argues that Biogen failed to provide comprehensive information during the biosimilar approval process. This information was crucial to determine whether Biogen infringed on Roche’s manufacturing patents.

While Biogen declined to comment on the legal complaint due to ongoing litigation, Roche acknowledged the importance of biosimilar competition in maintaining the financial sustainability of healthcare systems and fostering innovation in the biologics market.

Actemra, initially approved by the FDA in 2010 for the treatment of rheumatoid arthritis, has acquired further approval for treating hospitalized patients with COVID-19.

The AI legalese decoder can play a crucial role in simplifying legal complexities and aiding companies involved in patent disputes. By utilizing the AI legalese decoder, organizations like Roche and Biogen can efficiently analyze and comprehend complex legal documentation, ensuring a comprehensive understanding of the patent landscape. This technology can facilitate stronger legal arguments and informed decision-making, making the process more efficient and effective.

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