Biocon Biologics gets green light to launch Yesafili biosimilar in Canada

Biocon Biologics, a subsidiary of Biocon, on Monday officially announced a settlement with Bayer and Regeneron Pharmaceuticals. This agreement allows Biocon Biologics to launch Yesafili, a proposed biosimilar to EYLEA (aflibercept) Injection, in the Canadian market.

Under the agreement, Biocon Biologics will launch Yesafili no later than July 1, 2025. Health Canada had granted tentative approval for Yesafili in March 2023.

Under the terms of this agreement, Biocon Biologics has secured a launch date for Yesafili 2 mg New Drug Submission (NDS) for vials and prefilled syringes, with the launch set up to July 1, 2025. The announcement follows Health Canada's tentative approval in March 2023 for Yesafili 2 mg vials.

Yesafili is a biosimilar to Eylea, which is used to treat various eye diseases such as the 'wet' form of age-related macular degeneration (AMD), a condition affecting the central part of the retina, known as the macula. This form of AMD results from choroidal neovascularisation, characterised by abnormal blood vessel growth beneath the macula, potentially leading to fluid and blood leakage and subsequent swelling. Yesafili is also used for individuals experiencing impaired vision due to macular oedema resulting from conditions such as central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). The medication is also used in cases of impaired vision caused by macular oedema associated with diabetes and myopic choroidal neovascularisation, a severe form of short-sightedness characterised by abnormal eyeball growth.

This agreement occurred after the patent infringement proceedings in Canada were resolved, paving the way for Biocon Biologics to enter the Canadian market with Yesafili.

Biocon Biologics has been actively expanding its biosimilar portfolio globally. In November 2023, the company announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted marketing authorisation for Yesafili, a biosimilar of Aflibercept. In September of the same year, Yesafili received marketing authorisation approval from the European Commission (EC) for the European Union (EU).