Bio Usawa
Bio Usawa is a Rwanda-headquartered biotechnology company focused on developing, licensing, and manufacturing affordable monoclonal antibody therapeutics and biosimilars for patients in Africa. The organization is building local biologics manufacturing capacity, pursuing regulatory approvals in African markets, and supporting capacity-building, partnerships, and policy work to expand access to high-quality biologics across the continent.
Industries
Nr. of Employees
small (1-50)
Bio Usawa
San Francisco, California, United States, North America
Products
Ophthalmology biosimilar approved by Rwandan regulator
A biosimilar ophthalmology biologic developed and approved for market authorization by the Rwanda Food and Drugs Authority.
Ophthalmology biosimilar approved by Rwandan regulator
A biosimilar ophthalmology biologic developed and approved for market authorization by the Rwanda Food and Drugs Authority.
Services
End-to-end development and local manufacturing services for monoclonal antibody biosimilars targeted to African markets.
Regulatory affairs services covering dossier preparation, engagement with national and regional regulatory bodies, and strategy for WHO prequalification and market authorization.
Programs to support locally led research, microgrants, training, and partnerships with academic and clinical institutions in Africa.
End-to-end development and local manufacturing services for monoclonal antibody biosimilars targeted to African markets.
Regulatory affairs services covering dossier preparation, engagement with national and regional regulatory bodies, and strategy for WHO prequalification and market authorization.
Programs to support locally led research, microgrants, training, and partnerships with academic and clinical institutions in Africa.
Expertise Areas
- Clinical trial management for biologics
- Biologics manufacturing and scale-up
- Regulatory compliance and market authorization in Africa
- Analytical method development and separations
Key Technologies
- Monoclonal antibody therapeutics
- Biosimilar development
- Modular biomanufacturing facilities
- Biologics CMC and QA/QC systems
News & Updates
Company CEO participated in a plenary panel and roundtable at EAPB 2025, highlighted company progress and called for financing models adapted to African conditions; noted shipment scheduling of a modular manufacturing facility to Rwanda.
Recognition at AORTIC 2025 and launch of an AORTIC–Bio Usawa Microgrant Program supporting early and mid-career African cancer researchers.
Company CEO scheduled to speak on panels about strengthening local pharmaceutical manufacturing capacity and nurturing a sustainable pharma & biotech value chain in Africa.
Congratulatory statement acknowledging EFDA's regulatory Maturity Level 3 status and expressing intent to work closely with EFDA to enable access to quality biotherapies.
Announcement of regulatory market approval by the Rwanda FDA for a company-developed ophthalmology biosimilar.
Company CEO participated in a plenary panel and roundtable at EAPB 2025, highlighted company progress and called for financing models adapted to African conditions; noted shipment scheduling of a modular manufacturing facility to Rwanda.
Recognition at AORTIC 2025 and launch of an AORTIC–Bio Usawa Microgrant Program supporting early and mid-career African cancer researchers.
Company CEO scheduled to speak on panels about strengthening local pharmaceutical manufacturing capacity and nurturing a sustainable pharma & biotech value chain in Africa.
Congratulatory statement acknowledging EFDA's regulatory Maturity Level 3 status and expressing intent to work closely with EFDA to enable access to quality biotherapies.
Announcement of regulatory market approval by the Rwanda FDA for a company-developed ophthalmology biosimilar.