Brazil’s ANVISA grants marketing authorization to Lucentis biosimilar FYB201 (Ranivisio, Formycon/Bioeq AG)

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Formycon AG announced that the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis (ranibizumab, Genentech Inc.). Raniviso is the first Lucentis biosimilar to be approved by Brazil's health regulatory agency authority. FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Along with the regulatory decision, Formycon announced it has established a commercialization partnership with the Brazilian pharmaceutical company Biomm. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars.

Biomm's product launch of FYB201 is expected to occur in the fourth quarter of 2025, marking the beginning of a phased market rollout of FYB201 across Latin America. The regional regulatory authorities in Peru, El Salvador, Honduras and the Dominican Republic have already granted marketing authorisations for the biologic drug. Further approvals and product launches in Central and South America are planned through early 2027, according to the press release issued by Formycon.

Formycon Chief Business Officer Nicola Mikulcik stated, "The marketing approval of FYB201/Ranivisio in Brazil underlines our mission to improve access to high-quality biologic drug therapies, especially in countries where the use of high-cost biologics is quite limited today. We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil.”

FYB201 is used to treat severe visual impairments such as wet age-related macular degeneration and other retinopathies. The biosimilar is currently available in a total of 21 countries in Europe, North America, the Middle East and North Africa.

Reference

1. Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil. Press release. Formycon AG. Published June 5, 2025. Accessed June 5, 2025. https://www.formycon.com/blog/press-release/lucentis-biosimilar-fyb201-ranivisio-ranibizumab-in-brasilien-zugelassen/