• Partnership marks a landmark step towards global availability of FYB201
  • Bio Usawa gets exclusive rights to register and commercialize FYB201/BioUcenta™1 in Sub-Saharan Africa
  • Product launch expected in Q1/2026 in the first countries
  • Partnership will provide access to ophthalmic treatment for millions of people facing preventable blindness from diabetes complication

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that Bioeq AG (“Bioeq”), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon’s biosimilar candidate for Lucentis®2 (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd. (“Bio Usawa”).

This partnership grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta™, bringing a highly effective ophthalmic medicine within reach for millions of patients across Sub-Saharan Africa.

FYB201/ BioUcenta™ is a monoclonal antibody used to treat diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and other retinal diseases like diabetic retinopathy, that often lead to vision loss if not treated. While this therapy has been established in higher-income countries for nearly 20 years, patients across Africa have predominantly been denied access due to prohibitive costs and limited availability.

Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients.3

“By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. “This collaboration is about equity,” he added. “Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Formycon to make this a reality for Africa — ensuring that patients, regardless of where they live, can receive the care they deserve.”

“We are very excited to collaborate with Bio Usawa, who is a strong commercial partner with in-depth knowledge of the regional market and the specific requirements of the ophthalmology sector,” says Formycon CBO Nicola Mikulcik, adding: “This partnership represents a demonstration of the fulfillment of our joint mission to democratize access to high-quality, affordable, and proven biotherapies in low and middle income countries. This initiative should create the foundation of making essential medicines developed by Formycon available to the African continent.”

Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, FYB201 is currently available in a total of 21 countries.

 


  1. BioUcenta™ is a trademark of Bio Usawa Biotechnology Ltd.
  2. Lucentis® is a registered trademark of Genentech Inc.
  3. Source: IDF_Atlas_11th_Edition_2025_AFR_Factsheet.pdf