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Fresenius, a German healthcare company, could more than double its biosimilars portfolio, from 29 marketed and pipeline molecules to as many as 66, under an exclusive development agreement with WuXi Biologics announced Nov. 2. The agreement gives the company option rights on up to 37 potential first-to-market biosimilar candidates over the next decade. The candidates are aimed at originator drugs with more than €370 billion in list-price-based sales. Fresenius calls it the largest development agreement announced in the biosimilars industry to date.
Under the terms of the announcement, Fresenius will choose which candidates to develop, scoring each against what it calls its established criteria. Those criteria include market attractiveness, development risk and expected returns. It will pay WuXi Biologics on a fee-for-service basis for each candidate it selects, so research and development spending grows only as chosen programs advance. Fresenius will hold exclusive global commercialization rights, including the marketing authorizations, and the full economics of every product it brings to market under the deal. It also will decide where each product is made, with the option of moving selected products over time to mAbxience, its Spain-headquartered biosimilars unit within Fresenius Kabi. WuXi Biologics, a Hong Kong-listed contract research, development and manufacturing organization, will run development through its network in Europe, the United States, China and Singapore.
The first two programs target blockbuster biologics from Roche and Amgen. Polatuzumab vedotin, sold by Roche’s Genentech as Polivy, is an antibody-drug conjugate that delivers the microtubule-disrupting payload monomethyl auristatin E to CD79b-expressing B cells in diffuse large B-cell lymphoma. Roche reported Polivy sales of CHF 1.47 billion in 2025, up 38% at constant exchange rates. Teprotumumab, sold by Amgen as Tepezza, is a monoclonal antibody that blocks the insulin-like growth factor-1 receptor in thyroid eye disease, a rare autoimmune condition linked to Graves’ disease. Amgen reported U.S. Tepezza sales of $1.758 billion in 2025, down 4% from 2024.
Polivy would put an ADC into a portfolio built on antibodies and other proteins. Fresenius Kabi’s six U.S. biosimilars reference Humira, Prolia, Xgeva, Stelara, Neulasta and Actemra. Fresenius expects the WuXi Biologics portfolio to span 13 therapeutic areas, adding neurology, nephrology and cardiopulmonary medicine to its oncology, immunology and gastroenterology franchises, and to include monoclonal and bispecific antibodies, ADCs and fusion proteins.
“We are doubling down on our Biopharma business,” Fresenius CEO Michael Sen said in the announcement. “With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence.”
The WuXi Biologics agreement follows a month after Fresenius took full control of mAbxience. On Oct. 1, Fresenius announced it had bought the remaining 45% of mAbxience from Insud Pharma and Invim Corporativo for up to €750 million, including a contingent payment, in a deal completed Sept. 30. Fresenius Kabi had held a majority stake since August 2022, and mAbxience reported more than €320 million in 2025 revenue. In December 2025, Fresenius set a 2030 goal of roughly doubling Biopharma revenue from its 2025 level at an EBIT margin of about 20%, based on its marketed and late-stage portfolio. The company said the WuXi Biologics deal adds to that goal, that it expects to raise its long-term Biopharma ambitions significantly, and that it will fund the agreement from operating cash flow. Its full-year 2026 guidance stands unchanged.
The structure resembles the split in recent licensing deals between multinationals and Chinese drug developers: the Western company chooses the targets, and the Chinese partner builds the molecules. In October, Roche agreed to propose cancer targets for Hansoh Pharma to build ADCs against, with $400 million upfront and more than $15 billion in potential milestones, and Hansoh kept rights in mainland China, Hong Kong, Macau and Taiwan. In the Fresenius deal, WuXi Biologics works for a per-program fee, and Fresenius keeps worldwide rights and all product economics.
Fresenius said the number, timing and choice of candidates that enter development will depend on options it exercises one candidate at a time over the decade, starting with the Polivy and Tepezza programs.
Filed Under: Biologics, Drug Discovery
