Fresenius and WuXi Biologics Sign Exclusive Agreement Covering Up to 37 Biosimilar Candidates

Fresenius has signed an exclusive development agreement with WuXi Biologics that gives it options on up to 37 biosimilar candidates over the next decade, a move that could more than double its biosimilar portfolio.¹ The candidates span monoclonal and bispecific antibodies, antibody-drug conjugates (ADCs), and fusion proteins, and initial development will focus on biosimilars of the ADC polatuzumab vedotin and the monoclonal antibody teprotumumab.¹

“We are doubling down on our Biopharma business,” said Michael Sen, chief executive officer of Fresenius. “With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence.”¹

What does the agreement cover?

Under the agreement, Fresenius holds exclusive options on candidates across 13 therapeutic areas.¹ The deal expands Fresenius into neurology, nephrology, and cardiopulmonary indications while strengthening its positions in oncology, immunology, and gastroenterology.¹ If Fresenius exercises all of its options, its portfolio of marketed and pipeline molecules would grow from 29 to as many as 66.¹ The company said the candidate pool addresses more than €370 billion in originator list-price-based sales, a figure that reflects the reference products’ sales rather than projected Fresenius revenue.¹

WuXi Biologics, a contract research, development, and manufacturing organization, will be paid on a fee-for-service basis for each candidate Fresenius selects.¹ Development is expected to use WuXi Biologics’ global network, which spans Europe, the US, China, and Singapore.¹ Fresenius retains exclusive global commercialization rights, including marketing authorizations, and the full economics of any commercialized products.¹

Why does the modality mix matter?

No biosimilar ADC has been approved by FDA or the European Medicines Agency.² Unlike a conventional monoclonal antibody biosimilar, an ADC biosimilar must match the antibody, the linker, the payload, and the conjugation chemistry, including the distribution of drug-to-antibody ratios, which can affect safety.² Bispecifics add the challenge of correctly pairing heavy and light chains, since mispairing can reduce efficacy and increase immunogenicity, as BioPharm International® has reported. Fresenius cited WuXi Biologics’ track record in monoclonal and bispecific antibodies and ADCs as a factor in the agreement.¹

The scale of the deal reflects the cost pressures biosimilar developers face. In a BioPharm International interview, Anurag Rathore, PhD, professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi, discussed the economics of antibody manufacturing and access. “Most of the global population as of today cannot afford to take or avail of these best-in-class therapeutics,” Rathore said.

How does this fit with mAbxience?

The agreement follows Fresenius’ acquisition of the remaining 45% of mAbxience, its biosimilars subsidiary, for up to €750 million, a deal completed on September 30, 2026.³ mAbxience operates three multi-product drug substance manufacturing facilities in Spain and Latin America, has four marketed products and eight candidates in development, and generated more than €320 million in revenue in 2025.³ Fresenius said it will set the long-term manufacturing strategy for each new candidate, including a possible phased transfer of selected products to mAbxience.¹

“Combined with the full ownership of mAbxience, this fuels our Biopharma growth well beyond 2030,” Sen said.¹

How did investors respond?

Fresenius said it will fund the agreement from operating cash flow without new financing, and its 2026 guidance and 2030 Biopharma ambition remain unchanged.¹ The company expects to raise its longer-term Biopharma targets.¹

What happens next?

Whether and how many candidates advance depends on Fresenius exercising its options, and the company cautioned that there is no assurance any will reach the market.¹ Biosimilar competition continues to expand into newer biologics; in October, BioPharm International reported that FDA accepted a Biologics License Application for Formycon and Zydus’ FYB206, a proposed biosimilar to pembrolizumab (Keytruda).

References

1. Fresenius and WuXi Biologics enter exclusive development agreement to expand biosimilars pipeline. News release. Fresenius. November 2, 2026. Accessed November 2, 2026.
2. Zero for two: why no antibody-drug conjugate has ever faced a biosimilar. DrugPatentWatch. August 27, 2026. Accessed November 2, 2026.
3. Fresenius acquires remaining 45% of mAbxience for up to €750 million, taking full ownership of its biosimilars platform. News release. Fresenius. October 1, 2026. Accessed November 2, 2026.