Rwanda FDA Approves First Biosimilar Ranibizumab in Africa for Sight-Threatening Eye Diseases
Key Insights
The Rwanda Food and Drugs Authority (search) has granted market approval for Bio Usawa (search)'s BioUcenta (search)™, marking the first biosimilar ranibizumab approved in Africa for treating diabetic macular edema (search), age-related macular degeneration (search), and diabetic retinopathy (search).
BioUcenta (search)™ is expected to be priced up to 80 percent below Lucentis® (ranibizumab), addressing longstanding cost and supply barriers to sight-saving treatments across Sub-Saharan Africa.
The approval represents a major regulatory milestone for Rwanda-based Bio Usawa (search), which exclusively licensed the biosimilar from Bioeq AG (search) for Sub-Saharan Africa distribution.
The Rwanda Food and Drugs Authority (search) has granted market approval for Bio Usawa (search) Biotechnology Ltd.'s BioUcenta (search)™, a biosimilar of Lucentis® (ranibizumab) for treating diabetic macular edema (search), age-related macular degeneration (search), and diabetic retinopathy (search). This milestone marks the first biosimilar ranibizumab approved in Africa and represents Bio Usawa's first major regulatory achievement.
Addressing Critical Eye Health Needs in Africa
BioUcenta (search)™ is approved to treat serious eye diseases that are increasingly prevalent across Sub-Saharan Africa. As a biosimilar to Lucentis® (ranibizumab), the therapy offers a trusted treatment at a more accessible price point, addressing longstanding barriers to care. The product is expected to be priced as much as 80 percent below the price of Lucentis®, though Bio Usawa (search) has not yet announced specific pricing details.
"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," said Prof. Ciku Mathenge, a leading ophthalmologist and researcher based in Rwanda. "BioUcenta (search)™ represents hope for thousands at risk of vision loss, and Rwanda is leading the way in making advanced therapies accessible."
Regulatory Pathway and Timeline
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 (search) (EMA) to clear BioUcenta (search)™. The therapy is expected to be available in Rwanda starting Q1 2026.
The approval of BioUcenta (search)™, exclusively licensed from Bioeq AG (search) to Bio Usawa (search) for Sub-Saharan Africa, underscores the company's dual strategy of accelerating access to life-changing therapies through in-licensing partnerships while simultaneously developing local manufacturing capacity to ensure long-term sustainability across the continent.
Company Strategy and Future Outlook
"Receiving approval from Rwanda FDA marks a major milestone for Bio Usawa (search) 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.
Bio Usawa (search) 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.
The company's leadership team brings decades of experience from leading global biotech companies and international regulatory agencies. BioUcenta (search)™ serves as Bio Usawa (search)'s first flagship product as the company works to advance access to affordable, high-quality biosimilars and bio-betters across Africa.