Formycon AG has achieved a significant regulatory milestone with the approval of its Lucentis biosimilar FYB201/Ranivisio (ranibizumab) by Brazil's regulatory authority ANVISA, making it the first approved Lucentis biosimilar in the country. The German biopharmaceutical company announced that product launch is expected in Q4 2025 through a commercialization partnership with Brazilian pharmaceutical specialist Biomm.
Strategic Market Entry in Latin America
The Brazilian approval marks the beginning of a comprehensive Latin American market rollout for FYB201/Ranivisio. Marketing authorizations have already been secured in Peru, El Salvador, Honduras, and the Dominican Republic, with additional approvals and product launches planned across Central and South America 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," stated Formycon CBO Nicola Mikulcik. "We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil."
Market Opportunity and Partnership
Brazil represents the largest healthcare market in South America, with Biomm serving as Formycon's commercial partner. According to Biomm, the Brazilian market for anti-VEGF therapies, including ranibizumab, is valued at BRL 374 million (approximately US$ 66 million) annually and has demonstrated consistent growth over the past three years.
Biomm is a well-established pharmaceutical company with strong presence in Brazil, focusing on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars. The company brings in-depth knowledge of the local market and specific requirements of the ophthalmology sector.
Therapeutic Applications and Development
FYB201/Ranivisio (ranibizumab) is indicated for treating severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. The biosimilar was 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 across Europe, North America and the MENA region. Mikulcik noted that based on the country-by-country rollout in Latin America starting in Q4 2025, the company expects the region to become a good contributor to profits mid-term.
Broader Biosimilar Market Context
Formycon positions itself as a leading independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas. The company covers almost the entire value chain from technical development through clinical trials to regulatory approval.
With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market, with another biosimilar, FYB203/aflibercept, approved by the FDA, EMA, and MHRA. Four pipeline candidates are currently in development, contributing to the company's mission of providing patients with access to highly effective and affordable medicines.
