Fresenius has signed an exclusive development agreement with WuXi Biologics that gives it options on up to 37 biosimilar candidates over the next decade. Fresenius said on 2 November 2026 that the deal could lift its biosimilar portfolio from 29 marketed and pipeline molecules to as many as 66, across 13 therapeutic areas.
The German healthcare group called it the largest development agreement announced in the biosimilars industry to date. Fresenius will pay WuXi Biologics a fee for each candidate it chooses to develop. It keeps worldwide commercial rights to every product that reaches the market. The total value of the agreement and the fee per candidate were not disclosed.
- Scope: Exclusive options on up to 37 identified biosimilar candidates over the next decade.
- Portfolio: Fresenius says its biosimilar line-up could grow from 29 marketed and pipeline molecules to up to 66.
- Market size: The originator medicines involved have more than €370 billion in sales at list prices, according to Fresenius.
- First targets: Biosimilar versions of polatuzumab vedotin (Polivy) and teprotumumab (Tepezza).
- Payment: Fee-for-service for each candidate Fresenius selects; deal value not disclosed.
- Ireland: Fresenius Kabi already supplies five biosimilars to Irish prescribers, and four of their molecules are on the HSE's 2026 best-value list.
What did Fresenius and WuXi Biologics agree?
Fresenius SE & Co. KGaA announced the agreement from Bad Homburg, Germany, on 2 November 2026. WuXi Biologics, listed in Hong Kong as 2269.HK, is a contract research, development and manufacturing organisation for biologic medicines.
Under the deal, Fresenius gets exclusive access to up to 37 identified biosimilar candidates. Fresenius says these could be "first-to-market" biosimilars. It will decide which ones to advance, using three tests: market attractiveness, development risk and expected returns. Development is expected to run through WuXi Biologics' network in Europe, the United States, China and Singapore.
Fresenius will hold the marketing authorisations and the full economics of each product sold under the agreement. It will also decide where each product is made in the long term. One option is to move selected products, over time, to mAbxience, the Spain-headquartered biosimilar maker that Fresenius now fully owns.
Michael Sen, Chief Executive Officer of Fresenius, said: "We are doubling down on our Biopharma business. With this agreement we are gaining access to development capabilities in a market where speed and scale are of the essence."
Which medicines come first?
Fresenius says initial development is expected to focus on two medicines. The first is polatuzumab vedotin, sold as Polivy. It is an antibody-drug conjugate for diffuse large B-cell lymphoma. The second is teprotumumab, sold as Tepezza. It is a monoclonal antibody for thyroid eye disease, a rare autoimmune condition linked to Graves' disease.
The wider portfolio is expected to cover 13 therapeutic areas. Fresenius plans to move into neurology, nephrology and cardiopulmonary medicine. It also wants to strengthen its existing work in oncology, immunology and gastroenterology. The other 35 candidates have not been named.
| Item | Detail |
|---|---|
| Candidates covered | Up to 37, over the next decade |
| Fresenius portfolio today | 29 marketed and pipeline molecules |
| Possible portfolio | Up to 66 molecules |
| Therapeutic areas | 13 |
| Originator sales addressed | More than €370 billion at list prices |
| First candidates | Polatuzumab vedotin, teprotumumab |
| Payment model | Fee-for-service per selected candidate |
| Total deal value | Not disclosed |
| Funding | Operating cash flow, no new financing |
How does the deal fit with the mAbxience purchase?
The agreement follows a second biosimilar move by Fresenius only weeks earlier. On 1 October 2026, Fresenius said it had bought the remaining 45% of mAbxience from Insud Pharma and Invim Corporativo. The price was up to €750 million, including a contingent payment of €50 million linked to site approvals. The deal was signed and completed on 30 September 2026.
Fresenius first took a 55% stake in mAbxience in 2022. According to Fresenius, mAbxience runs three drug substance plants in Spain and Latin America and employs more than 1,300 people. It had revenue of more than €320 million in 2025. It has four products on the market and eight in development.
What does it mean for Fresenius' finances?
Fresenius says its full-year 2026 guidance is unchanged. It also kept its 2030 Biopharma ambition, first set out in December 2025. That goal is to roughly double Biopharma revenue compared with 2025, at an EBIT margin of around 20%. Fresenius says the new deal is extra to that goal.
Fresenius says research and development spending, and therefore Biopharma profitability, will reflect higher investment as candidates advance. The deal is funded from operating cash flow.
Is there an Irish connection?
Yes, on both sides, though neither company has said any work under this agreement will take place in Ireland.
WuXi Biologics has a drug substance manufacturing site at Mullagharlin, Dundalk, Co Louth. The company announced the €325 million investment in April 2018, with plans for 400 jobs over five years. In a May 2025 update, WuXi Biologics said the Dundalk site ran on 100% certified renewable electricity in 2024 and employed people from 27 nationalities.
Fresenius Kabi's Irish website lists five biosimilars for Republic of Ireland healthcare professionals. These are Idacio (adalimumab), Tyenne (tocilizumab), Otulfi (ustekinumab), and Bomyntra and Conexxence (both denosumab). Fresenius Kabi also runs KabiCare Ireland, a support service for patients on its biosimilars.
Four of those molecules appear on the HSE Medicines Management Programme's 2026 list of medicines that may go through a best-value biological process. They are adalimumab, denosumab, tocilizumab and ustekinumab. Under this process, the HSE names preferred biosimilar products and asks prescribers to start new patients on them. Priya Life Science has reported on how much the HSE could save by using more biosimilars.
Readers can follow Fresenius on our Fresenius company page and track new US approvals in our FDA biosimilars register.
Frequently asked questions
How many biosimilars are covered by the agreement?
Up to 37 identified candidates over the next decade. Fresenius will choose which ones to develop, so the final number could be lower.
How much is Fresenius paying WuXi Biologics?
Not disclosed. Fresenius says it will pay on a fee-for-service basis for each candidate it selects, so spending grows only as programmes advance.
Has WuXi Biologics commented?
At the time of writing, WuXi Biologics had not published a press release or an HKEXnews announcement on the agreement. The details here come from Fresenius.
Will the work happen in Dundalk?
Neither company has said so. Fresenius says development is expected to use WuXi Biologics' global network, and that Fresenius will decide long-term manufacturing for each product.
Outlook
The first test will be progress on the polatuzumab vedotin and teprotumumab programmes. Fresenius has not given timelines for development, regulatory filings or launches. Biosimilar launches also depend on when patents and other protections expire in each market. Priya Life Science will update this story if WuXi Biologics publishes its own announcement.
Sources
- Fresenius, Fresenius and WuXi Biologics enter exclusive development agreement to expand biosimilars pipeline, 2 November 2026
- Fresenius, Fresenius acquires remaining 45% of mAbxience for up to €750 million, taking full ownership of its biosimilars platform, 1 October 2026
- Contract Pharma, Fresenius, WuXi Biologics Sign Biosimilars Deal, 2 November 2026
- WuXi Biologics, WuXi Biologics to Invest €325 Million to Build Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland, 30 April 2018
- WuXi Biologics, WuXi Biologics Ireland: Delivering Measurable Sustainability Progress Through Purposeful Innovation, 13 May 2025
- Fresenius Kabi Ireland, Biopharma products for Republic of Ireland healthcare professionals, accessed 3 November 2026
- HSE Medicines Management Programme, Best-value biological (BVB) medicines / Best-value medicines (BVM) 2026, January 2026
- HKEXnews, Listed company announcements search (WuXi Biologics, stock code 2269), checked 3 November 2026
Cover image: AI-generated illustration.
