Fresenius strikes WuXi biosimilars deal for up to 37 assets, targeting €370B market

Handshake M&A
Through its partnership with WuXi Biologics, Fresenius will expand its biosimilar portfolio across 13 therapeutic areas and multiple biologic technologies. (Stock photo/Getty Images)

Fresenius has inked a broad deal with WuXi Biologics to secure exclusive options for up to 37 new biosimilar candidates, which could scale its portfolio to 66 molecules targeting a combined originator market worth over 370 billion euros ($415 billion).

The partnership will initially focus on Roche’s blood cancer antibody-drug conjugate Polivy and Amgen’s thyroid eye disease therapy Tepezza, both blockbusters on a growing trajectory.

Under the fee-for-service agreement, Fresenius can select and advance biosimilar candidates individually based on its own criteria—including market size, development risk and expected returns—while retaining full commercialization economics of products. In other words, WuXi is only offering its development capabilities.

The German company didn’t disclose any other financial terms in its Nov. 2 announcement. In a Monday note, Jefferies analysts interpret the fee-for-service deal structure as including no upfront or milestone payments. The company will report third-quarter earnings on Nov. 4

“We are doubling down on our Biopharma business,” Fresenius CEO Michael Sen said in a statement. “With this agreement, we are gaining access to development capabilities in a market where speed and scale are of the essence. It provides a disciplined, scalable way to potentially triple our portfolio while retaining economic ownership, strategic control and the flexibility to allocate capital to the most compelling opportunities.”

The 37 potential first-to-market biosimilar candidates will be added to Fresenius over a decade. The sheer number of assets involved makes the deal the largest development agreement in the biosimilars industry to date, Fresenius noted. 

The WuXi alliance puts Fresenius in a horse race with other industry heavyweights like Sandoz, which is aggressively expanding its own biosimilar footprint under its “Bio100” initiative. Under that plan, Sandoz aims to establish a portfolio of more than 100 biosimilars by 2040, up from the 13 it currently markets. 

Dealmaking in the biosimilar space has visibly ramped up as pharmas face a heavy loss-of-exclusivity period, which opens what’s known as a biosimilar “void.” In August, Sandoz licensed three biosimilars from China’s Henlius Biotech, with the potential to expand to seven other candidates. Last month, Teva expanded its collaboration with Samsung Bioepis to cover up to six additional biosimilar programs.

In total, Fresenius aims to expand its biosimilar portfolio to as many as 66 molecules, targeting branded drugs with combined sales of more than 370 billion euros at list prices. The company’s nine marketed products now represent about 85 billion euros, Jefferies’ analysts noted.

This expanded portfolio will span 13 therapeutic areas, including Fresenius’ existing positions in oncology, immunology and gastroenterology, while expanding it into neurology, nephrology and cardiopulmonary. It also encompasses multiple biologic technologies, including monoclonal and bispecific antibodies, ADCs and fusion proteins. 

While the deal won’t affect Fresenius’ 2026 guidance or its 2030 goal of approximately doubling its biopharma revenue compared with 2025, the company said it expects to raise its long-term ambitions significantly.

To support its expansion plans, Fresenius recently acquired the remaining 45% stake in biosimilar manufacturer mAbxience, taking full ownership of the company. In its Nov. 2 announcement, Fresenius said it would evaluate manufacturing options for each drug developed by WuXi, including potentially using mAbxience’s manufacturing network.