Fresenius is expanding its biosimilars strategy through an exclusive development agreement with WuXi Biologics that could add as many as 37 candidates to its portfolio over the next decade. The agreement provides Fresenius with access to a broader range of biologic drug development programs while allowing the company to retain control over candidate selection, manufacturing decisions, and global commercialization.

The companies said the collaboration represents the largest development agreement announced in the biosimilars industry to date. It could increase Fresenius’ marketed and pipeline portfolio from 29 molecules to as many as 66, targeting originator products with combined sales exceeding $410 billion, based on list prices.

Under the arrangement, Fresenius will have exclusive access to the identified candidates and decide which programs move forward based on market potential, development risk, and anticipated returns. The company will retain exclusive global commercialization rights, including marketing authorizations, as well as the full commercial economics for products it brings to market. The expanded portfolio is expected to cover 13 therapeutic areas, including new opportunities in neurology, nephrology, and cardiopulmonary medicine. It will also build on Fresenius’ existing positions in oncology, immunology, and gastroenterology.

The development programs will encompass several biologic modalities, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and fusion proteins. Initial development efforts are expected to include polatuzumab vedotin, an ADC used to treat diffuse large B-cell lymphoma, and teprotumumab, a monoclonal antibody for thyroid eye disease.

Fresenius CEO Michael Sen says the agreement will provide access to development capabilities needed to compete in a market where manufacturing scale and development speed are increasingly important. He added that the collaboration offers a way to substantially expand the company’s pipeline while maintaining strategic control and directing investment toward the most attractive opportunities.

WuXi Biologics will conduct development activities through its international network, which includes operations in Europe, the United States, China, and Singapore. The company brings experience in large-scale biologics development and manufacturing, including monoclonal and bispecific antibodies and ADCs.

The agreement complements Fresenius’ recent acquisition of full ownership of mAbxience, the Spain-headquartered biopharmaceutical company. Fresenius will determine the long-term manufacturing approach for each selected biosimilar, with the option to progressively transfer production of certain products to the mAbxience network.

The collaboration is part of a broader pipeline strategy that combines internal research and development, targeted partnerships, and selective licensing. By pairing WuXi Biologics’ development capabilities with Fresenius’ manufacturing and commercialization infrastructure, the companies aim to create additional opportunities across the biologics value chain.

Financial commitments under the agreement will be structured on a fee-for-service basis. Fresenius will pay WuXi Biologics for each candidate it selects for development, with research and development spending increasing as individual programs advance. This structure allows Fresenius to evaluate opportunities before committing resources to full development programs. The additional investment is expected to increase Biopharma research and development expenses during the development phase, with the potential for revenue and profitability contributions as products reach the market.

Fresenius expects to raise its longer-term Biopharma ambitions as the expanded pipeline progresses. The agreement will be funded through operating cash flow and is not expected to require new financing. Fresenius also said it will maintain its focus on balance-sheet strength and continued debt reduction. The partnership gives Fresenius a substantially larger pool of potential biosimilar programs while allowing it to retain decision-making authority over which candidates advance and how they are ultimately manufactured and commercialized.

For more information, visit www.fresenius.com.