Fresenius is making a major push to strengthen its position in the global biosimilars market, striking an exclusive development agreement with WuXi Biologics that could nearly triple its portfolio from 29 to as many as 66 molecules.

 

The agreement gives Fresenius exclusive access to up to 37 identified biosimilar development candidates over the next decade, in what the company describes as the largest development agreement announced in the biosimilars industry to date. The targeted portfolio addresses more than €370 billion in originator list-price-based sales, opening up a significantly larger growth opportunity for the German healthcare group.

 

Under the deal, Fresenius will retain exclusive global commercialization rights, including marketing authorizations, as well as the full economics of every product brought to market. The partnership is designed to accelerate pipeline expansion while preserving strategic control, investment discipline and flexibility in capital allocation.

 

Michael Sen, Chief Executive Officer of Fresenius, said: “We are doubling down on our Biopharma business. With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence. It provides a disciplined, scalable way to potentially triple our portfolio while retaining economic ownership, strategic control and the flexibility to allocate capital to the most compelling opportunities. Combined with the full ownership of mAbxience, this fuels our Biopharma growth well beyond 2030.”

 

The expanded portfolio is expected to cover 13 therapeutic areas, marking a significant broadening of Fresenius’ presence in biologic medicines. Alongside strengthening its established positions in oncology, immunology and gastroenterology, the company plans to enter new therapeutic areas, including neurology, nephrology and cardiopulmonary diseases.

 

The pipeline will span several advanced biologic technologies, including monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins. Initial development efforts are expected to focus on polatuzumab vedotin, an antibody-drug conjugate used in the treatment of diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for thyroid eye disease.

 

The partnership brings together WuXi Biologics’ large-scale biologics development and manufacturing capabilities with Fresenius’ global manufacturing and commercialization infrastructure. WuXi Biologics has an established track record in monoclonal and bispecific antibodies and antibody-drug conjugates, supported by an international network spanning Europe, the United States, China and Singapore.

 

Development programmes will be selected based on Fresenius’ established criteria, with market attractiveness, development risks and expected returns determining which candidates move forward. Development activities are expected to leverage WuXi Biologics’ global network.

 

The deal is part of Fresenius’ broader strategy to expand its biosimilars pipeline through a combination of internal research and development, strategic partnerships and selective in-licensing. It also builds on the recent acquisition of Spain-headquartered mAbxience, which strengthened Fresenius’ wholly owned biopharma platform.

 

By securing access to a much larger pool of potential development candidates, Fresenius aims to capture greater value across the entire biopharmaceutical value chain — from development and manufacturing to global commercialization.

 

The scale of the agreement signals an aggressive long-term bet on biosimilars as a key growth engine for Fresenius. With access to up to 66 molecules and a target market representing more than €370 billion in originator list-price-based sales, the company is positioning its Biopharma business for expansion well beyond its 2030 growth ambitions.