March 5, 2025 Kigali, Rwanda and San Francisco, USA

The senior leadership team of Biousawa, including CEO Dr. Menghis Bairu, COO Dr.Patrick Lukulay, and Global Head of Regulatory Affairs, Eric Karikari-Boateng, recently held a consultative meeting with the technical team and heads of department at the Rwanda Food and Drugs Authority (Rwanda FDA). The meeting focused on the regulatory pathway and facility design for Biousawa’s state-of-the-art biotechnology plant in Rwanda.

During the discussions, the Rwanda FDA provided invaluable input on the facility design, ensuring compliance with international regulatory standards. 

Dr. Menghis Bairu, CEO of Biousawa, emphasized the importance of this collaboration, stating, “This partnership with the Rwanda FDA marks a pivotal step in our journey to establish a world-class biotechnology manufacturing facility in Africa. By leveraging local expertise and regulatory support, we are poised to deliver life-saving therapies that will alleviate the burden of chronic diseases and improve the quality of life for millions.”

The Rwanda FDA’s commitment to supporting Bio Usawa’s vision underscores the shared goal of advancing healthcare innovation and self-reliance in Africa. The agency’s proactive engagement and guidance will enable Bio Usawa to accelerate the development of its facility and ensure the timely availability of high-quality, affordable biologics for patients in need.

Biousawa’s biotechnology plant will not only serve as a hub for the production of monoclonal antibodies but also create opportunities for local talent development, technology transfer, and economic growth. This initiative aligns with our vision to establish regional manufacturing plants and create regional Centers of Excellence in healthcare innovation and manufacturing.

Biousawa extends its gratitude to the Rwanda FDA for their collaboration and looks forward to continued partnership as the project progresses. Together, we are committed to building a healthier future for Africa.

About Bio Usawa, Inc. (BUI)

Bio Usawa has a singular mission: to manufacture high-quality, effective and affordable biosimilars for patients in Africa. We are applying our 100+ years of combined experience in the industry in partnership with governments, agencies, educators and health professionals to make transformative biomedicines in Africa, by Africans, for Africans and beyond. 

Click here to learn more about our company's recent successes and download our new White Paper on Regulatory Approaches to Biosimilars in Africa.