Fresenius partners with WuXi Biologics to access 37 biosimilar candidates, potentially expanding its portfolio to 66 molecules across 13 therapeutic areas.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
Fresenius SE & Co. KGaA has entered an exclusive development agreement with WuXi Biologics to access up to 37 potential first-to-market biosimilar candidates over the next decade. The agreement could expand Fresenius’ combined marketed and pipeline portfolio from 29 to 66 molecules, targeting originator biologics with combined annual sales exceeding €370 billion and extending its Biopharma growth horizon beyond 2030.
Largest Biosimilar Development Agreement to Date
The agreement gives Fresenius exclusive access to 37 identified biosimilar candidates, making it the largest development agreement announced in the biosimilars industry to date.
- Strategic Control: Fresenius will independently select which candidates to advance based on market attractiveness, development risk, and expected commercial returns.
- Commercial Ownership: Importantly, the company will retain exclusive global commercialization rights, including marketing authorizations, and the full commercial economics of each product developed under the agreement.
- Flexible Capital Structure: This structure allows Fresenius to expand its pipeline without committing development capital across all 37 candidates upfront. WuXi Biologics will provide research, development, and manufacturing services on a fee-for-service basis, with Fresenius funding individual programs only when it exercises its options to advance selected candidates.
Portfolio Expands Across 13 Therapeutic Areas
The proposed portfolio spans 13 therapeutic areas and multiple biologic technologies, including monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), and fusion proteins.
The expansion will strengthen Fresenius’ existing positions in oncology, immunology, and gastroenterology while opening growth opportunities in neurology, nephrology, and cardiopulmonary diseases. Initial development is expected to focus on two established reference therapies:
- Polatuzumab vedotin: An anti-CD79b antibody-drug conjugate marketed as Polivy for diffuse large B-cell lymphoma (DLBCL). The therapy combines a CD79b-targeting monoclonal antibody with the microtubule-disrupting agent monomethyl auristatin E (MMAE) to deliver a cytotoxic payload directly to malignant B cells.
- Teprotumumab: A monoclonal antibody marketed as Tepezza for thyroid eye disease (TED), an autoimmune condition associated with Graves’ disease. It inhibits insulin-like growth factor-1 receptor (IGF-1R) signaling, reducing inflammation and tissue remodeling in orbital tissues.
Both therapies represent high-value reference biologics with substantial clinical demand and clear opportunities for biosimilar entry.
Manufacturing Strategy Integrates mAbxience
The agreement reinforces Fresenius’ manufacturing strategy following its acquisition of the remaining 45% stake in Spanish biologics manufacturer mAbxience in October 2026, bringing the business under full ownership.
While WuXi Biologics will support early development activities across its international network in Europe, the United States, China, and Singapore, Fresenius retains ultimate control over long-term manufacturing strategy. The company plans to progressively transfer manufacturing of selected products to mAbxience, capturing end-to-end value across development, manufacturing, and commercialization.
Financial Strategy and Post-2030 Outlook
Fresenius confirmed that its full-year 2026 financial guidance remains unchanged. The company also maintained its ambition (set in December 2025) to approximately double Biopharma revenue by 2030 compared to 2025 levels, while targeting an EBIT margin of around 20%.
Because these targets apply strictly to its existing marketed and late-stage portfolio, the WuXi agreement provides incremental growth upside beyond 2030, supporting a significant increase in long-term Biopharma ambitions.
- Capital Allocation: Development expenditure will scale progressively as selected programs advance.
- Funding: The expansion will be funded through operating cash flow without requiring new debt, preserving the company’s existing financial framework and deleveraging priorities.
“This collaboration provides a scalable approach to expanding our Biopharma portfolio while retaining strategic control and full economic ownership,” stated Fresenius CEO Michael Sen.
Strategic Conclusion
Beyond the sheer candidate volume, combining WuXi Biologics’ R&D capabilities with Fresenius’ global commercial network and wholly owned mAbxience manufacturing platform creates a robust framework for long-term competitiveness in biosimilars. Final commercial impact will depend on candidate selection, execution timelines, manufacturing efficiency, and market dynamics at launch.
Reference
Fresenius and WuXi Biologics enter exclusive development agreement to expand biosimilars pipeline, Fresenius, 02 November 2026
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.