European Commission Approves First Aflibercept Biosimilar

The European Commission, the final division of the European Medicine Agency (EMA) needed for a drug approval within the European Union, announced the approval of Yesafili, an aflibercept biosimilar indicated for ophthalmic conditions.

Yesafili was developed by Biocon Biologics, the biosimilars division of Biocon, and will be used to treat neovascular age-related macular degeneration, macular edema, and myopic choroidal neovascularization. It references Eylea and is the first aflibercept biosimilar to be approved for the region.

“We are very pleased to receive the European Commission’s approval of our Yesafili biosimilar as we continue to expand our biosimilar offerings across the globe, building on our oncology and diabetes product portfolio. We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy,” said a Biocon Biologics spokesperson in a company statement.

Untreated age-related macular degeneration (AMD) is the leading cause of irreversible blindness or vision loss in people over 60 years of age. Although wet AMD, accounts for only 10% of AMD cases, this subset of the disease results in 90% of legal blindness as a result of AMD.

The approval came after the EMA’s Committee for Medicinal Products for Human Use gave a positive opinion for the drug in July 2023, and it was the first aflibercept biosimilar to receive a thumbs up from the division. The news also came after Biocon published its quarterly earnings report, which showed that the company’s biosimilar global sales rose 106% compared with the same quarter the year prior.

Formycon, Celltrion and Samsung Bioepis are also working on their respective aflibercept biosimilars. The approval of Yesafili applies to all EU member states as well as countries in the European Economic Area, including Iceland, Liechtenstein, and Norway.

Aflibercept products are inhibitors for vascular endothelial growth factor (anti-VEGF) that are administered intravitreally. When treating eye conditions, anti-VEGF medicines stop the abnormal blood vessels leaking, growing and then bleeding under the retina, which can cause intense pain and vision loss for patients.

According to Genentech, the maker of Lucentis—another anti-VEGF medication—untreated age-related macular degeneration (AMD) is the leading cause of irreversible blindness or vision loss in people over 60 years of age. Neovascular AMD, also known as wet AMD, accounts for 10% of AMD cases but results in 90% of legal blindness as a result of AMD.

The originator, generated approximately $1.8 billion in 2022. For comparison, there are also no federally approved aflibercept biosimilars in the United States, Canada, Australia, United Kingdom, or Brazil.

Yesafili is the twelfth anti-VEGF product to be approved by the European Commission, joining 3 ranibizumab biosimilars (Ranivisio, Ximluci, and Byooviz) and 8 bevacizumab biosimilars (Vegzelma, Alymsys, Oyavas, Aybintio, Onbevzi, Mvasi, Zirabev, and Abevmy).

Ranibizumab products have the same indications as aflibercept, except ranibizumab is also indicated for diabetic retinopathy. Although bevacizumab products are regularly used to treat conditions like wet AMD, because the reference product (Avastin) is only indicated for oncologic conditions, bevacizumab biosimilars and Avastin can only be used for ophthalmic conditions off-label.

Reference

Biocon Biologics Receives European Commission Approval for YESAFILI®, Biosimilar Aflibercept. News release. Biocon Biologics; September 20, 2023. Accessed September 21, 2023. https://www.biocon.com/biocon-biologics-receives-european-commission-approval-for-yesafili-biosimilar-aflibercept/