Germany-based Fresenius SE & Co. KGaA has entered an exclusive development agreement with China's WuXi Biologics, a leading global contract organisation for research, development and manufacturing. The agreement significantly expands and accelerates Fresenius' biosimilars pipeline while preserving strategic flexibility and disciplined capital allocation. It provides access to a scalable pathway to increase the portfolio from 29 marketed and pipeline molecules today to up to 66 molecules, addressing more than €370 billion in originator list-price-based-sales, extending Biopharma growth in the long term beyond its 2030 ambition.
The agreement provides Fresenius with exclusive access to up to 37 identified biosimilar candidates over the next decade, making it the largest development agreement announced in the biosimilars industry to date.
Development programmes will be selected and advanced against Fresenius' established selection criteria, based on market attractiveness, development risk, and expected returns. Fresenius will hold exclusive global commercialisation rights, including marketing authorisations, and the full economics of each commercialised product under the agreement.
The next-generation portfolio is expected to span 13 therapeutic areas, including expanding into neurology, nephrology and cardiopulmonary, while further strengthening Fresenius' established positions in oncology, immunology, and gastroenterology. It will encompass multiple biologic technologies, including monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins.
Initial development is expected to focus on polatuzumab vedotin, an antibody-drug conjugate for the treatment of diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for the treatment of thyroid eye disease.
Under the terms of the agreement, Fresenius will compensate WuXi Biologics on a fee-for-service basis for each biosimilar candidate that Fresenius selects for development.
