Rwanda has approved BioUcenta™, a lower-cost drug similar to Lucentis® (ranibizumab), to treat diabetic macular edema, an age-related macular degeneration and diabetic eye condition.
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The Rwanda Food and Drugs Authority (Rwanda FDA) approved the drug made by Bio Usawa Biotechnology on Monday, October 20, making it the first biosimilar ranibizumab authorized in Africa, the company said on Tuesday.
The drug developed through an exclusive license from Swiss company Bioeq AG, is expected to reach the Rwandan market in early 2026.
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BioUcenta™ delivers the same benefits as Lucentis® but is expected to cost as much as 80% less. The exact price has not yet been confirmed.
Diabetic macular edema (DME), a condition that affects the retina and can lead to permanent vision loss, is one of the diseases treated by BioUcenta™. It is estimated that 7 to 10 percent of people with diabetes develop DME.
While anti-VEGF injections like ranibizumab are the standard treatment in high-income countries, their high cost often puts them out of reach of many patients in sub-Saharan Africa.
The Rwanda FDA approved the drug using an accelerated process based on data already reviewed by the European Medicines Agency (EMA). The agency is recognized by the World Health Organization as a Maturity Level 3 authority, which allows it to speed up approvals by using international standards.
"Receiving approval from Rwanda FDA is a great milestone for Bio Usawa as we continue to consolidate our position in the biosimilar market," said Dr. Menghis Bairu, the company CEO and president.
"More importantly, it shows Rwanda’s commitment to ensuring patients have access to the very best care."
In an interview with The New Times, Dr. John Nkurikiye, Chief Ophthalmologist and Director of the Rwanda International Institute of Ophthalmology (RIIO), discussed the potential impact of the new treatment on common eye diseases.
"Conditions like diabetic macular edema, retinal vein occlusions, and age-related macular degeneration require anti-VEGF medication, which is the standard treatment," he said.
"However, the high cost and limited availability have made it hard for many patients to get this medicine."
Nkurikiye added that the recent approval and plans to manufacture the drug in Rwanda will make a difference, noting that this will improve access and change the lives of many patients.
Rwanda is positioning itself as a regional hub for biopharmaceutical production, for instance, in November 2024, Bio Usawa Inc. signed an agreement with the Rwanda Development Board (RDB) to build the country’s first monoclonal antibody manufacturing plant.
The facility is expected to produce medicines locally, starting with treatments for eye diseases and later expanding to cancer and other serious conditions.