Fresenius partners with WuXi Biologics to expand biosimilar pipeline to 66 molecules
The collaboration will initially focus on biosimilar versions of Roche’s cancer treatment Polivy and Amgen’s thyroid eye disease therapy Tepezza.
GERMANY – Fresenius has partnered with WuXi Biologics to secure exclusive options for up to 37 biosimilar candidates, expanding its development pipeline and targeting branded medicines with combined originator sales exceeding €370 billion (US$415 billion).
The collaboration will initially focus on biosimilar versions of Roche’s cancer treatment Polivy and Amgen’s thyroid eye disease therapy Tepezza.
Both are established biologic medicines with growing commercial markets.
Under the fee-for-service agreement, WuXi Biologics will provide development services, while Fresenius will decide which candidates to advance based on market potential, development risks and expected returns.
The German healthcare group will retain commercial rights and the economic benefits of products it chooses to develop.
Fresenius did not disclose the financial terms in its November 2 announcement. However, Jefferies analysts suggested that the arrangement does not include upfront or milestone payments. Fresenius was scheduled to report its third-quarter results on November 4.
“We are doubling down on our Biopharma business,” said Fresenius CEO Michael Sen, explaining that the partnership would provide access to development capabilities while allowing the company to retain strategic control and allocate capital selectively.
Expanding the biosimilar pipeline
Fresenius expects to add the 37 potential biosimilar candidates over the next decade.
If all options progress, the company’s portfolio could reach 66 molecules, compared with its nine marketed products, which currently target originator medicines with combined sales of approximately €85 billion (US$95 billion), according to Jefferies analysts.
The expanded pipeline will cover 13 therapeutic areas, including oncology, immunology, gastroenterology, neurology, nephrology and cardiopulmonary diseases.
It will also include several biologic formats, such as monoclonal and bispecific antibodies, antibody-drug conjugates (ADCs) and fusion proteins.
Fresenius described the arrangement as the largest development agreement in the biosimilars industry to date.
The company expects the partnership to support its ambition to significantly expand its biopharmaceutical business, although it will not change its 2026 financial guidance or its 2030 target of approximately doubling biopharma revenue from 2025 levels.
Competition intensifies in biosimilars
The agreement comes as pharmaceutical companies prepare for patent expirations affecting major biologic medicines.
These expirations create opportunities for biosimilar developers to introduce lower-cost alternatives and compete for market share.
Fresenius will compete with established players, including Sandoz, which plans to build a portfolio of more than 100 biosimilars by 2040 under its Bio100 initiative, compared with the 13 products it currently markets.
Other companies are also expanding their partnerships. In August, Sandoz licensed three biosimilar candidates from China’s Henlius Biotech, with options to expand the collaboration to seven additional candidates.
Teva also extended its partnership with Samsung Bioepis in October to include up to six additional biosimilar development programmes.
Manufacturing strategy
To support its expansion, Fresenius recently acquired the remaining 45% stake in biosimilar developer mAbxience, giving it full ownership of the company.
Fresenius said it would assess manufacturing arrangements for each candidate developed with WuXi Biologics, including the potential use of mAbxience’s production network.
This approach gives Fresenius flexibility to combine external development expertise with its own manufacturing capabilities as individual candidates advance towards commercialisation.
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