KIGALI, Rwanda and SAN FRANCISCO, Oct. 20, 2025 (GLOBE NEWSWIRE) -- The Rwanda Food and Drugs Authority has granted market approval for Bio Usawa Biotechnology Ltd.’s (Bio Usawa) BioUcenta™, a biosimilar of Lucentis® (ranibizumab) for the treatment of diabetic macular edema, age-related macular degeneration and diabetic retinopathy.
The approval of BioUcenta™, exclusively licensed from Bioeq AG to Bio Usawa for Sub Saharan Africa, is the first biosimilar ranibizumab approved in Africa and represents the first major regulatory milestone for Bio Usawa.
Established to advance access to affordable, high-quality biosimilars and bio-betters across Africa, Bio Usawa is introducing BioUcenta™—a biosimilar for the treatment of sight-threatening eye diseases—as its first flagship product. The approval underscores the company’s dual strategy: accelerating access to life-changing therapies through in-licensing partnerships while simultaneously developing local manufacturing capacity to ensure long-term sustainability across the continent.
BioUcenta™ is approved to treat serious eye diseases that are increasingly prevalent across Sub-Saharan Africa. As a biosimilar to Lucentis® (ranibizumab), BioUcenta™ offers a trusted therapy at a more accessible price point, addressing longstanding barriers to care.
“Receiving approval from Rwanda FDA marks a major milestone for Bio Usawa as we continue to consolidate our position in the biosimilar market. More importantly, it underscores Rwanda’s commitment to ensuring patients have access to the very best care,” said Dr. Menghis Bairu, CEO and President of Bio Usawa.
Prof. Ciku Mathenge, a leading ophthalmologist and researcher based in Rwanda, added, “This approval is a breakthrough for eye health in Africa. For too long, as doctors become increasingly frustrated by erratic supplies of these crucial medications while our patients are frustrated by the high cost, patients have gone without sight-saving treatment. BioUcenta™ represents hope for thousands at risk of vision loss, and Rwanda is leading the way in making advanced therapies accessible.”
Rwanda FDA, recognized by the World Health Organization as a Maturity Level 3 (ML3) regulatory authority, used an accelerated pathway referencing data already approved by the European Medicines Agency (EMA) to clear BioUcenta™. The therapy is expected to be available in Rwanda starting Q1 2026. Although the company has not yet announced pricing for the product, it is expected to be priced as much as 80 percent below the price of Lucentis®.
About Bio Usawa, Inc.
Bio Usawa is Rwanda's pioneering biotechnology company dedicated to democratizing access to life-saving biotherapeutics across Africa. Founded on the principle that geographic location should not determine healthcare outcomes, the company specializes in developing and manufacturing affordable, high-quality monoclonal antibodies targeting cancer, diabetes complications, infectious diseases, and autoimmune conditions. Bio Usawa's leadership team brings decades of experience from leading global biotech companies and international regulatory agencies. For more information, visit www.biousawa.com.
About Bioeq AG
Bioeq AG is a biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Bioeq develops and licenses biosimilars for global markets, combining innovation and quality to improve patient access to vital therapies. Learn more at www.bioeq.ch.
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