Bio Usawa

What Bio Usawa does

Bio Usawa is a privately-held biotechnology company developing and manufacturing affordable monoclonal antibody therapeutics for patients in Africa. Founded in 2017 and headquartered in San Francisco (Delaware-incorporated), the company operates a platform-plus-products model anchored by BioMod™, a modular end-to-end biomanufacturing platform deployed in Rwanda that enables local production of biosimilars at approximately one-tenth the cost of US pricing. The company's first commercial product, BioUcenta™, is a biosimilar of Lucentis® (ranibizumab) approved by the Rwanda Food and Drugs Authority in October 2025 as the first biosimilar ranibizumab approved in Africa, with planned availability from Q1 2026. The pipeline targets oncology/hematology, immunology, ophthalmology, and infectious disease indications.

The company supplements its manufacturing platform with an exclusive worldwide licensing agreement (up to $500M) with Nanoly Bioscience for DynaShield™, a polymer scaffold thermal stabilization technology that shields biologics and vaccines from degradation, eliminating cold chain requirements and addressing an estimated $20-35B in annual cold chain losses globally. Bio Usawa generates revenue through biosimilar product sales to African healthcare systems and government tenders, sublicensing of DynaShield™ to third parties, and technology transfer/manufacturing services. Its go-to-market is enterprise field sales targeting Ministries of Health, national regulatory authorities (Rwanda FDA, Ghana FDA, AMA), hospitals, and specialty centers across Africa, with operational hubs in Rwanda (manufacturing), Kenya (East Africa regional), and Ghana (regulatory). Leadership includes former Pfizer and Genentech executives, including a former Pfizer Chief Medical Officer appointed to the Board in June 2026.

Name

Bio Usawa

Legal name

Bio Usawa Inc.

Website

https://biousawa.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Bio Usawa is a privately-held biotechnology company that develops and manufactures affordable monoclonal antibody biosimilars (oncology, ophthalmology, immunology, infectious disease) for patients in Africa, using its modular BioMod™ biomanufacturing platform deployed in Rwanda and licensed DynaShield™ cold-chain-elimination technology.

Ownership category

akta.pro rank

Product category

Biosimilar Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody (mAb) Biosimilars (HLAIAFAA)

akta.pro secondary industries

Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF), Bioprocess Facility, Cleanroom & Utility Systems (HVAC, WFI, CIP/SIP, containment) (HLAAAJAJ)

Keywords

• Monoclonal antibody biosimilars
• Biopharmaceutical manufacturing services
• Cold chain stabilization technology
• Biosimilar cancer therapeutics
• Ophthalmic biosimilar therapies

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Biosimilar Product Sales: Revenue generated from developing, manufacturing, and selling biosimilar monoclonal antibody therapeutics to healthcare systems, hospitals, and specialty clinics across Africa. BioUcenta™ (biosimilar of Lucentis®) is the first approved product planned for availability in Rwanda from Q1 2026. Additional pipeline products target oncology, immunology, and infectious disease indications.
2. Licensing and Sublicensing of DynaShield™: Up to $500 million strategic licensing agreement with Nanoly Bioscience grants Bio Usawa exclusive worldwide rights to use and sublicense DynaShield™ technology. This generates revenue through sublicensing arrangements with third-party manufacturers and distributors.
3. Technology Transfer and Manufacturing Services: Revenue from providing biomanufacturing capabilities, technology transfer, and related services to partners and governments seeking to build local biotechnology capacity in Africa.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Bio Usawa develops, manufactures, and supplies affordable biosimilar monoclonal antibody therapeutics for cancer, ophthalmic, autoimmune, and infectious disease indications across African healthcare systems. Its lead commercial product is BioUcenta™, a biosimilar of Lucentis® (ranibizumab) approved by Rwanda FDA in October 2025 as the first biosimilar ranibizumab approved in Africa, produced at its BioMod™ modular biomanufacturing facility in Rwanda with planned availability from Q1 2026. The company also licenses DynaShield™ thermal stabilization technology for cold-chain-free biologic distribution and offers technology transfer and biomanufacturing services to African governments and partners.

Product overview

Bio Usawa is a biotechnology company developing and manufacturing high-quality, affordable monoclonal antibody therapeutics for patients in Africa. The company operates a platform-plus-products model centered on BioMod™, a modular end-to-end biomanufacturing platform deployed in Rwanda, which enables local production of biosimilars including BioUcenta™ (the first approved biosimilar ranibizumab in Africa) and other monoclonal antibody therapeutics. The company also licenses the DynaShield™ technology for thermal protection of biologics. Products target oncology/hematology, immunology, and ophthalmology therapeutic areas, with the goal of providing lifesaving medicines at about one-tenth the cost compared to the United States.

Differentiator

Problem solved

Functional benefit

Brands

• BioUcenta™: Biosimilar of Lucentis® approved by Rwandan FDA for treating eye diseases, specifically the first biosimilar ranibizumab approved in Africa.
• BioMod™
• DynaShield™

Products and services

• BioUcenta™ Biosimilar of Lucentis® (ranibizumab) approved by the Rwanda Food and Drugs Authority for the treatment of eye diseases (ophthalmology indications). It is the first biosimilar ranibizumab approved in Africa, intended for distribution to African hospitals and specialty ophthalmology centers, with planned availability in Rwanda from Q1 2026 at approximately one-tenth the cost in the United States.
• Biosimilar Monoclonal Antibody Therapeutics (Oncology, Immunology, Infectious Disease Pipeline) Pipeline of affordable, high-quality biosimilars of monoclonal antibodies covering oncology/hematology, immunology, ophthalmology, and infectious disease indications, intended for sale to African healthcare systems, hospitals, and specialty clinics.
• Biopharmaceutical Manufacturing and Technology Transfer Services Biomanufacturing services, technology transfer, and capacity-building services provided to African governments, ministries of health, and pharmaceutical partners seeking to establish local biotechnology production capabilities using the BioMod™ modular platform.
• DynaShield™ Technology Sublicensing Exclusive worldwide rights (licensed in from Nanoly Bioscience) to use and sublicense the DynaShield™ polymer scaffold thermal stabilization technology, which keeps biologics and vaccines stable outside refrigeration and addresses the estimated $20–35 billion in annual losses from temperature control failures globally.

Quantifiable outcome

• Biosimilar monoclonal antibodies produced at approximately one-tenth the cost in the United States
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Nanoly BiosciencecoreOEM/ Whitelabel/ Licensing Partner · 18 February 2026Bio Usawa and Nanoly Bioscience entered a definitive licensing agreement valued at up to $500 million, granting Bio Usawa exclusive worldwide rights to use and sublicense the DynaShield™ technology. DynaShield™ uses a specialized polymer scaffold to shield biologics and vaccines from thermal degradation, allowing them to remain stable outside of refrigeration for extended periods. The collaboration aims to reduce the estimated $20–35 billion in annual losses from temperature control failures and significantly decrease vaccine wastage rates, particularly in regions with limited refrigeration infrastructure. The technology is particularly relevant for Africa where cold chain infrastructure is limited.

Scale indicators10 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Biocon Biologics: One of the largest biosimilar manufacturers globally with a strong emerging-markets and Africa commercial footprint. Comparable to Bio Usawa as both are biosimilar developers targeting affordability, but Biocon is far larger and broader in portfolio.
• Samsung Bioepis: Major Korean biosimilar manufacturer with an extensive mAb biosimilar pipeline (ranibizumab, bevacizumab, adalimumab, etc.) and growing global distribution including partnerships in emerging markets. Direct portfolio overlap with Bio Usawa's planned biosimilar mAbs.
• Celltrion: Korean biosimilar leader with approved mAb biosimilars (rituximab, trastuzumab, infliximab) and expanding global reach. Comparable as a large-scale mAb biosimilar competitor that may eventually enter African markets.
• Coherus Biosciences: US biosimilar-focused biopharma where Bio Usawa board member Vince Anicetti was formerly COO/Head of Global Quality. Direct portfolio overlap (ranibizumab biosimilar, oncology mAbs) and comparable pure-play biosimilar strategy.
• Amgen: Originator of several biologic blockbusters (e.g., ranibizumab originator through Roche/Novartis for Lucentis) and increasingly active in biosimilars. A broad incumbent whose reference products Bio Usawa targets with biosimilars.

Direct peers

• mAbxience: Global biosimilar company (part of Insud Pharma) with manufacturing in Spain and Argentina focused on affordable mAb biosimilars for global health, including emerging markets. Closely comparable in mission, scale, and product focus.
• Hetero Biopharma: Indian biosimilar and biologics manufacturer with affordable mAb biosimilars and Africa/emerging-market distribution focus. Comparable cost-driven model and product portfolio overlap.

Regional players

• Institut Pasteur de Dakar: African vaccine and biologics manufacturer based in Senegal building local vaccine capacity for the continent. Comparable mission of African self-sufficiency in biologics manufacturing, though focused on vaccines rather than mAb therapeutics.
• Aspen Pharmacare: South African-headquartered pharma company with strong African distribution and manufacturing footprint, including vaccines and biologics. Comparable as an Africa-focused pharma incumbent that Bio Usawa may partner with or compete against for public tenders.

Others

• Nanoly Bioscience: Technology licensor and Bio Usawa's exclusive worldwide DynaShield™ partner. Compares as an enabling technology provider in the same cold-chain-elimination ecosystem.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries2 records

Funding overview

Funding rounds3 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bio Usawa