• Raniviso® becomes first approved Lucentis® biosimilar in Brazil
  • Commercialization partnership established with Brazilian pharmaceutical company Biomm
  • Product launch in Brazil expected in Q4 2025, kicking off the commercial rollout of FYB201 across Latin America
  • Further market approvals of FYB201/Ranivisio® granted in Central and South America

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio®1, a biosimilar to Lucentis®2 (ranibizumab). Product launch by the Brazilian biopharma specialist Biomm is expected in Q4 2025, marking the beginning of a phased market rollout of FYB201/Raniviso® across Latin America. Marketing authorizations have already been granted by the regional regulatory authorities in Peru, El Salvador, Honduras, and the Dominican Republic. Further approvals and product launches in Central and South America are planned through early 2027.

“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 usage of high-cost biologics is quite limited today,” says Formycon CBO Nicola Mikulcik, adding: “We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil. In Biomm, we have a strong commercial partner with in-depth knowledge of the local market and the specific requirements of the ophthalmology sector. Based on the country-by-country rollout in LATAM, which is planned to start in Q4 this year, we expect the region to become a good contributor to our profits mid-term.”

Biomm is a well-established pharmaceutical company with a strong presence in Brazil, the largest healthcare market in South America. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars. According to Biomm, the Brazilian market for anti-VEGF therapies, including the active ingredient ranibizumab, is valued at BRL 374 million (approx. US$ 66 million) annually and has demonstrated consistent growth over the past three years.

FYB201/Ranivisio® (ranibizumab) is used to treat severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, the biosimilar is currently available in a total of 21 countries in Europe, North America and the MENA region.


1Ranivisio® is a registered trademark of Bioeq
2Lucentis® is a registered trademark of Genentech Inc.