Fresenius, a Germany-based healthcare company with a biopharmaceutical business, has entered an exclusive development agreement with WuXi Biologics, a China-headquartered contract research, development and manufacturing organization (CRDMO), to expand its biosimilars pipeline. The agreement gives Fresenius exclusive option rights to up to 37 biosimilar candidates, potentially increasing its marketed and pipeline portfolio from 29 molecules to as many as 66 over the next decade.

The candidates address originator products with more than €370 billion in combined sales based on list prices, according to Fresenius. The company will select which programs to advance using criteria that include market attractiveness, development risk and expected returns. Fresenius will retain exclusive global commercialization rights, including marketing authorizations and the full economics of products it takes through development.

The portfolio is expected to span 13 therapeutic areas, including oncology, immunology, gastroenterology, neurology, nephrology, and cardiopulmonary conditions. It will include monoclonal and bispecific antibodies, antibody-drug conjugates (ADCs), 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.

Under the agreement, WuXi Biologics will provide development services for candidates selected by Fresenius, who will pay for each program on a fee-for-service basis, with research and development investment increasing as individual candidates progress. Development activities are expected to use WuXi Biologics’ global network, which spans Europe, the United States, China and Singapore.

Fresenius will determine the long-term manufacturing strategy for each candidate, including the potential transfer of selected products to mAbxience, its wholly owned biosimilars development and manufacturing platform. The agreement gives Fresenius flexibility to use its own manufacturing network as programs advance while retaining control over commercialization.

The agreement is additive to Fresenius’ existing 2030 biopharma ambition, which calls for approximately doubling biopharma revenue compared with 2025 at an earnings-before-interest-and-taxes margin of about 20%. The company said the new pipeline opportunities are expected to support growth beyond 2030. Its full-year 2026 financial guidance remains unchanged. Development spending will increase as selected programs advance, with the agreement funded through operating cash flow.

The deal follows Fresenius’ acquisition of the remaining 45% stake in mAbxience, announced Oct. 1, which gave it full ownership of the biosimilars developer and manufacturer. Fresenius acquired a 55% majority stake in 2022. The business operates three multi-product drug substance manufacturing facilities in Spain and Latin America, supporting biosimilar monoclonal antibody production and contract manufacturing services. Full ownership gives Fresenius greater control over manufacturing capacity, investment decisions, and the platform’s development and commercialization strategy.