Rwanda Food and Drugs Authority has approved BioUcenta, a biosimilar of Ranibizumab, for market authorization. It is the first such approval in Africa. On the surface, this may sound like just another regulatory announcement. But, in truth, it is a watershed moment for healthcare access that speaks volumes about Africa’s growing scientific self-reliance and Rwanda’s growing leadership in enabling it. ALSO READ: Rwanda, Bio Usawa ink deal to manufacture affordable eye treatments in Africa For decades, advanced biologic treatments, including those for vision-threatening diseases like age-related macular degeneration and diabetic retinopathy, have been available in high-income countries but remained out of reach for African patients. These are conditions that rob millions of people of their sight, often in their most productive years. ALSO READ: First Rwandan pharmaceutical manufacturer begins operations in September Across Sub-Saharan Africa, an estimated 26 million people live with vision impairment, and over two-thirds of those cases are preventable or treatable. The tragedy is not that the science didn’t exist; it is that access didn’t. BioUcenta’s approval hopefully marks the beginning of the end of that injustice. “This approval is a breakthrough for eye health in Africa,” said Prof. Wanjiku Mathenge, one of the continent’s leading ophthalmologists. “For too long, patients have gone without sight-saving treatment due to high costs.” ALSO READ: How Kigali is becoming Africa’s biopharma capital A biosimilar is a biological medicine that is highly similar to an already-approved reference product (like Ranibizumab for the BioUcenta case), offering the same clinical benefits but at a lower cost. In markets such as Europe and the United States, biosimilars helped drive down the cost of biologic therapies significantly, expanding patient access and easing the financial burden on healthcare systems. Prof. Mathenge, who is also a co-founder of Rwanda International Institute of Ophthalmology (RIIO), added: “BioUcenta represents hope for thousands at risk of vision loss, and Rwanda is leading the way in making advanced therapies accessible.” While BioUcenta’s prices are yet to be made public, early projections suggest it could cost as little as 20% of the global average price – a change that could make vision-saving care attainable for millions who were previously left out. BioUcenta, according to Bio Usawa officials, is exclusively licensed from originator Bioeq AG for distribution across Sub-Saharan Africa, in what is seen as a model of equitable collaboration that ensures global innovation reaches African patients. For Rwanda, the milestone is not an isolated triumph. It reflects years of investment in regulatory science, health innovation, and clear political will to position the country as a regional hub for biomedical excellence. Rwanda FDA’s attainment of WHO ML3 status, a global benchmark for regulatory maturity, is not just symbolic. It signifies that Rwanda’s regulator meets rigorous international standards for evaluating and approving medical products. And now, with BioUcenta’s approval, the standards are translating into real outcomes that improve lives. Dr. Menghis Bairu, CEO and President of Bio Usawa, noted that the decision “marks a major milestone for Bio Usawa. More importantly, it underscores Rwanda’s commitment to ensuring patients have access to the very best care.” The symbolism of Rwanda being the first country to authorize this biosimilar is profound. It reflects a nation unafraid to lead – to set standards, not just follow them. In doing so, Rwanda is helping redefine Africa’s place in the global biopharmaceutical value chain. This moment also poses a challenge to the rest of the continent. If Rwanda can achieve this level of regulatory readiness and enable access to cutting-edge biologics, why not others? The answers lie in investment, collaboration, and political will. BioUcenta’s approval is a statement of possibility that access to life-changing treatment does not have to be a privilege of geography or wealth. Because when a person in Kigali can receive the same quality of care as a patient in Berlin or Boston, that is not just progress. That is justice. The author is a partnerships strategist. He writes on African development, innovation, and policy.
