Polpharma Biologics Partners with Libbs Farmacêutica to Bring Autoimmune Biosimilar to Brazilian Market
Key Insights
Polpharma Biologics (search) has signed a landmark licensing agreement with Brazilian pharmaceutical company Libbs Farmacêutica (search) for exclusive commercialization rights of an autoimmune disease biosimilar (search) in Brazil.
The biosimilar (search) therapy is currently under development and expected to be submitted to Brazil's regulatory agency Anvisa for approval within three years.
Libbs currently treats more than 15 million patients and operates Brazil's first industrial-scale monoclonal antibody manufacturing plant, positioning the company to expand access to biological therapies.
Polpharma Biologics (search), a Swiss-based biopharmaceutical company specializing in biosimilar (search) development and manufacturing, has entered into a strategic licensing agreement with Brazilian pharmaceutical company Libbs Farmacêutica (search) to commercialize a biosimilar for autoimmune diseases (search) exclusively in the Brazilian market. The partnership represents a significant expansion opportunity for both companies in addressing unmet medical needs in Latin America's largest pharmaceutical market.
Strategic Partnership Structure
Under the terms of the agreement, Polpharma Biologics (search) retains full responsibility for the development and manufacturing of the biosimilar (search), while Libbs Farmacêutica (search) will hold exclusive rights for commercialization, marketing, and distribution throughout Brazil. This division of responsibilities leverages each company's core strengths and market expertise.
"Entering the Brazilian market with a biosimilar (search) is a significant step for Polpharma Biologics (search) and reflects our ongoing mission to expand access to high-quality, affordable biological treatments worldwide," said Anjan Selz, CEO of Polpharma Biologics. "Our collaboration with Libbs Farmacêutica (search), a company with deep knowledge of the Brazilian market, provides us with strong commercial expertise. Combined with our development and manufacturing capabilities, this partnership will significantly increase access to biological therapies for people in Brazil who are living with autoimmune diseases (search)."
Development Timeline and Regulatory Path
The biosimilar (search) medicine is currently under development and is expected to be submitted to Anvisa, Brazil's national health surveillance agency, for regulatory approval within three years. The therapy is described as offering an effective and well-tolerated treatment option for patients living with autoimmune conditions.
Market Impact and Patient Access
Libbs Farmacêutica (search) brings substantial market reach to the partnership, currently treating more than 15 million patients through its existing product portfolio. The company operates across multiple therapeutic areas including cardiology, dermatology, gastroenterology, gynecology, hematology, oncology, central nervous system, and respiratory system.
"This partnership with Polpharma Biologics (search) is fully aligned with Libbs' strategy of investing in a diversified portfolio of medicines with potential to further expand the Brazilian population's access to healthcare," said Alcebíades de Mendonça Athayde Junior, CEO of Libbs.
Manufacturing Capabilities
Libbs operates Brazil's first industrial-scale monoclonal antibody manufacturing facility, known as Biotec. In 2024, the company expanded its capabilities by adding a Pilot Plant dedicated to the development of biomolecules, scaling up bioprocesses, and producing clinical material for studies through partnerships or as a contract development and manufacturing organization (CDMO).
The Brazilian pharmaceutical company maintains a robust portfolio comprising 97 product brands across over 200 presentations, spanning reference drugs, similar products, chemotherapeutics, and biosimilars including monoclonal antibodies (search). Libbs invests approximately 10% of its revenue in research and development activities and maintains initiatives such as the Research Incentive Program (PIP), which supports independent clinical studies.
Company Backgrounds
Polpharma Biologics (search) operates as a Swiss-based entity managing the entire biosimilar (search) value chain from product selection and investment allocation to program execution and asset monetization. The company's biosimilar portfolio includes programs spanning from early development to commercial stages across various major therapeutic areas.
Libbs, established 67 years ago, employs 4,000 people and has been recognized for eight consecutive years as one of the best companies to work for in Brazil according to Great Place to Work (GPTW). The company describes its mission as "transforming knowledge into health" and maintains a focus on collaborative processes and continuous improvement in delivering high-quality pharmaceutical products and solutions.