Lucentis Biosimilar FYB201/Ranivisio (ranibizumab) Approved In Brazil

• 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

Formycon AG today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio¹, a biosimilar to Lucentis² (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$ 66M 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.

About Formycon:
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich. For more information, visit https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Biomm:
Biomm SA was born with the mission of developing, manufacturing and commercializing biomedicines with global competitiveness, quality and accessibility, bringing the best treatments to a growing number of people.

Founded in 2001, during a split-up process of a major global insulin manufacturer, Biomm is the first and only Brazilian company totally focused on biotechnology. For more information, visit www.biomm.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.