A ranibizumab biosimilar developed by Swiss biotechnology company Bioeq AG (Bioeq) has been successfully submitted to the US Food and Drug Administration (FDA) for review.
Ranibizumab can be used to treat macular degeneration by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss.
US-based Coherus BioSciences (Coherus) announced on 1 October 2021 that FDA had accepted the application for their proposed biosimilar, CHS-201. The application for CHS-201 (also known as FYB201) was submitted by Bioeq, which is a joint venture of Poland-based Polpharma Biologics and German-based Santo Holding. Coherus acquired rights to commercialize Bioeq’s ranibizumab biosimilar (FYB201) in the US in 2019 [1].
The product is a proposed biosimilar of blockbuster wet AMD treatment Lucentis (ranibizumab) marketed by Genentech (Roche)/Novartis. Lucentis estimated global sales of approximately US$3.5 billion in 2020. The patents on Lucentis expired in the US in June 2020 and will expire in Europe in 2022 [2].
FDA has set a Biosimilar User Fee Act action date for 2 August 2022, and, if approved, Coherus plans to launch the ranibizumab biosimilar in the US in the second half of 2022. Subject to FDA’s approval, CHS-201 will be exclusively commercialized by Coherus in the US.
Coherus already has a biosimilar approved in the US, Udenyca (pegfilgrastim-cbqv) [3], which the company launched in January 2019. In addition, its adalimumab biosimilar candidate, CHS-1420, was submitted to FDA for review in February 2021 [4] and has a target action date of December 2021. Finally, its bevacizumab biosimilar candidate, CHS-305, is currently being evaluated in a comparative pharmacokinetic study in healthy subjects to support a potential biosimilar filing in 2022 [5].
Bioeq also submitted applications for its proposed ranibizumab biosimilar to the European Medicines Agency in June 2021 [6] and to the UK’s Medicines and Healthcare products Regulatory Agency in July 2021.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Coherus signs licensing deal for bevacizumab biosimilar in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/pharma-news/Coherus-signs-licensing-deal-for-bevacizumab-biosimilar-in-the-US
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
6. GaBI Online - Generics and Biosimilars Initiative. Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/biosimilars/news/formycon-bioeq-submit-european-marketing-authorization-for-ranibizumab-biosimilar
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Source: Coherus, Polpharma Biologics
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