Polpharma Biologics, Formycon and Bioeq jointly announced on 2 August 2022 that they had received approval from the US Food and Drug Administration (FDA) for their ranibizumab biosimilar (CHS-201/FYB201).
Cimerli (ranibizumab-eqrn) is a biosimilar that is interchangeable with blockbuster wet age-related macular degeneration (AMD) treatment Lucentis (ranibizumab) marketed by Genentech (Roche)/Novartis. Lucentis had estimated global sales of approximately US$3.5 billion in 2020, before the advent of biosimilars .
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab .
FYB201 was developed by Swiss biotechnology company Bioeq, a joint venture between Poland-based Polpharma Biologics and Germany-based Formycon.
US-based Coherus BioSciences (Coherus) announced in 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. Coherus acquired rights to commercialize Bioeq’s ranibizumab biosimilar (FYB201) in the US in 2019 .
Cimerli has been approved by FDA for the treatment of neovascular (wet) (nAMD) and other serious retinal diseases. This covers all five indications of the originator biological Lucentis and includes diabetic macular oedema, diabetic retinopathy, macular oedema following retinal vein occlusion and myopic choroidal neovascularization. According to Coherus, the approval also comes with ‘12 months of interchangeability exclusivity’.
The FDA approval and interchangeability designation are based on a totality of evidence including analytical, non-clinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of Cimerli were found to be comparable to the reference drug Lucentis in patients with (wet) nAMD. Clinical results from the randomized, double-masked, parallel group, multi-centre phase III study (COLUMBUS AMD) were also submitted as part of the comprehensive clinical data package.
The ranibizumab biosimilar (CHS-201/FYB201) also received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use on 24 June 2022 . In Europe, Teva Pharmaceutical Industries has acquired distribution rights from Bioeq and will be responsible for commercialization of FYB201 in Europe .
Canada approves ranibizumab biosimilar Byooviz
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
3. 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 2022 Aug 26]. Available from: www.gabionline.net/pharma-news/Coherus-signs-licensing-deal-for-bevacizumab-biosimilar-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201
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Source: Coherus, Formycon, Polpharma Biologics, US FDA