Fresenius, WuXi Biologics Sign Biosimilars Development Deal

Fresenius has entered an exclusive development agreement with WuXi Biologics that gives it exclusive access to up to 37 potential first-to-market biosimilar candidates over the next decade. The company called it the largest development agreement announced in the biosimilars industry to date.

The deal could expand Fresenius' portfolio from 29 marketed and pipeline molecules today to up to 66 molecules, addressing more than €370 billion in originator list-price-based sales. The next-generation portfolio is expected to span 13 therapeutic areas, expanding into neurology, nephrology and cardiopulmonary while strengthening existing positions in oncology, immunology and gastroenterology. It will cover monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins.

Initial development is expected to focus on polatuzumab vedotin, an ADC for diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for thyroid eye disease.

Fresenius will select and advance candidates against its established criteria of market attractiveness, development risk and expected returns. It will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product. Fresenius will compensate WuXi Biologics on a fee-for-service basis for each candidate it selects. The company will also determine the long-term manufacturing strategy for each candidate, including potential progressive transfer of selected products to mAbxience, which it has wholly owned since October 2026.

CEO Michael Sen said the agreement provides a disciplined, scalable way to potentially triple the portfolio while retaining economic ownership, strategic control and capital allocation flexibility.


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