Fresenius bets its biosimilar pipeline on WuXi Biologics: up to 37 molecules

Fresenius signed an exclusive option deal for up to 37 biosimilar candidates developed by WuXi Biologics, pay-as-you-go and with all commercial rights staying in Germany. It is the clearest sign yet that Western buyers still want Chinese biologics capacity, as long as the contract keeps the exit door open.

2026-11-02

Less than a year after the BIOSECURE Act became US law, a major Western drugmaker has just handed a Chinese CDMO the largest biosimilar development program on record. On November 2, Fresenius (XETR: FRE) took exclusive option rights to up to 37 biosimilar candidates from WuXi Biologics (HKEX: 2269) over the next decade. For Asia, the signal is that China's biologics platforms still win global work on speed and scale. The catch: the contract is written so Fresenius can move manufacturing elsewhere later.

What was signed

According to the Fresenius announcement, the deal would take its biosimilar portfolio from 29 marketed and pipeline molecules to as many as 66. Together, the reference products account for more than €370 billion in originator sales at list prices. The candidates cover 13 therapeutic areas and four modalities: monoclonal antibodies, bispecifics, antibody-drug conjugates and fusion proteins.

The first two programs are named. One is a biosimilar of polatuzumab vedotin (Polivy), an ADC for diffuse large B-cell lymphoma. The other is teprotumumab (Tepezza), an IGF-1R antibody for thyroid eye disease. Few companies have tried to copy an ADC so far, and choosing one as an opening program shows what WuXi is being paid for: its conjugation capacity, not just routine antibody cell-line work.

The economics: no upfront, no milestones, no royalties

This is not a licensing deal of the kind Chinese innovators have been signing all year, so it should not be read through the "upfront versus biobucks" lens. Fresenius holds exclusive global commercialization rights, the marketing authorizations and the full economics of each product. WuXi Biologics is paid fee-for-service for each candidate Fresenius chooses to option. R&D spend scales only as programs advance. Fresenius says it will fund the deal from operating cash flow and is keeping its 2026 guidance unchanged.

For WuXi Biologics, that means a long, predictable stream of service revenue but no share of the products' success. For Fresenius, the costs are flexible and it keeps all the upside. The commercial value to WuXi depends on how many of the 37 options Fresenius actually exercises, and no figure has been disclosed for that.

The clause that matters: manufacturing can leave

The release says development will run on WuXi's global network. Fresenius will set the long-term manufacturing strategy for each product, and that could include gradually transferring production to mAbxience. Fresenius bought the remaining 45% of mAbxience on October 1, 2026, making it a wholly owned biosimilar unit. The release does not name WuXi as the commercial manufacturer.

That is how a China CDMO contract looks under BIOSECURE. The Act was enacted on December 18, 2025, as part of the FY2026 NDAA. The US Office of Management and Budget must publish its first list of biotechnology companies of concern by December 18, 2026. Legal analyses of the law so far do not report WuXi Biologics on any designation list. Even so, a buyer that sells into US federal channels has reason to separate development, where China's cost and speed advantage is largest, from commercial supply, where political risk sits. Fresenius has built that separation into the deal from the start.

What it means for Asian biosimilar players

For Korea's Samsung Bioepis and Celltrion, the competitive pressure is pipeline breadth. Up to 66 molecules, including ADCs and bispecifics, would put Fresenius among the broadest biosimilar portfolios worldwide. For Chinese biosimilar developers such as Henlius (HKEX: 2696) and Bio-Thera (SSE: 688177), the deal shows that Western partners now buy development capacity directly from CDMOs instead of licensing finished assets. That makes it harder to sell a late-stage biosimilar to a European partner.

For Taiwan's ADC and biologics CDMOs, there is an opening and a warning. The opening: if Fresenius and others later move commercial supply out of China, they will need qualified non-China capacity for complex modalities. The warning: WuXi has shown it can win a decade-long, 37-molecule mandate. Matching that takes scale and a regulatory track record, not just lower political risk.

What to watch

How many options Fresenius exercises in the first two years, and whether WuXi Biologics reports the deal's contribution to its backlog.
The OMB list of biotechnology companies of concern due by December 18, 2026, and whether any WuXi entity appears on it.
Whether other generic and biosimilar majors sign similar option-style deals with Chinese CDMOs, or move toward Korean, Indian and Taiwanese capacity instead.
Regulatory filings for the polatuzumab vedotin biosimilar, an early test of how ready regulators are for ADC biosimilars.

Sources

This article is industry and company analysis, not investment or medical advice.