Bio Usawa Receives Ghana FDA Approval for BioUcenta™

Ghana follows Rwanda in approving BioUcenta™, Africa’s first approved ranibizumab biosimilar

ACCRA, Ghana and KIGALI, Rwanda, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Bio Usawa Biotechnology Ltd. (Bio Usawa, Inc.) today announced that the Ghana Food and Drugs Authority (Ghana FDA) has approved BioUcenta™, a biosimilar to Lucentis® (ranibizumab), for the treatment of diabetic macular edema, age-related macular degeneration, and diabetic retinopathy.

This approval follows closely on the heels of authorization by the Rwanda FDA, underscoring growing regulatory momentum for biosimilars across Africa and paving the way for broader regional access to life-saving biologic therapies. BioUcenta™ is licensed exclusively to Bio Usawa for Sub-Saharan Africa by Bioeq AG.

The Ghana FDA’s approval was granted following a rigorous, science-based regulatory review that referenced comprehensive data previously evaluated and accepted by the European Medicines Agency (EMA). This milestone further advances Bio Usawa’s mission to expand access to high-quality, affordable biologics across the continent.

“This second national approval, coming so quickly after Rwanda’s, is a powerful signal,” said Eric Karikari-Boateng, Bio Usawa’s Head of Global Regulatory Strategy. “It shows that African regulators are ready to act decisively when strong scientific evidence supports quality, efficacy and safety."

BioUcenta™ is the first ranibizumab biosimilar approved in both Ghana and Rwanda, with additional authorizations expected in other African markets in the coming months. The approval of a biosimilar to an innovator biologic presents a significant opportunity to reduce treatment costs and expand patient access.

Bio Usawa’s entry into ophthalmology marks the first phase of its broader plan to expand access to biosimilars across therapeutic areas such as oncology and autoimmune disease.

“Every approval strengthens the foundation for a new model of biotherapeutic access in Africa,” said Patrick Lukulay, PhD, Chief Operating Officer of Bio Usawa. “BioUcenta™ embodies our mission to close the gap between innovation and accessibility.”

Final pricing for BioUcenta™ has not yet been announced, but Bio Usawa expects it to be offered at a significantly lower price than the originator.

About Bio Usawa
Bio Usawa is Africa’s pioneering biotechnology company dedicated to democratizing access to life-saving biotherapeutics. Headquartered in Kigali, Rwanda, the company develops, licenses, and manufactures affordable monoclonal antibodies and biosimilars targeting cancer, diabetes complications, infectious diseases, and autoimmune conditions.

About Bioeq AG
Bioeq AG is a European biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. The company develops and licenses biosimilars for global markets, combining innovation and quality to expand patient access to vital therapies.

Media Contact:
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Levine Media Group
+1 510-280-5405
danny@levinemediagroup.com

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