Fresenius gets exclusive access to up to 37 WuXi Biologics biosimilar candidates

Fresenius SE & Co. KGaA now has exclusive access to up to 37 identified biosimilar candidates from WuXi Biologics over the next decade, the company said in a release. Fresenius pays WuXi Biologics a fee for service for each candidate it selects for development, and it holds exclusive global commercialization rights, including marketing authorizations, so the development work for a selected candidate sits with a contract organization while the product rights stay with Fresenius.

Why it matters

The release names two products for initial development: polatuzumab vedotin, sold as Polivy, and teprotumumab, sold as Tepezza. The DailyMed label for Polivy, revised 8/2026, lists use in combination with "a rituximab product, cyclophosphamide, doxorubicin, and prednisone" for adults with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL), who have an International Prognostic Index score of 2 or greater. The same label lists use with bendamustine and a rituximab product in adults with relapsed or refractory DLBCL, NOS, after at least two prior therapies.

The DailyMed label for Tepezza, revised 9/2026, states: "TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration."

Terms the release states

The release is dated Nov. 2, 2026, from Bad Homburg, Germany.

Scope: up to 37 identified biosimilar candidates over the next decade, in 13 therapeutic areas.
Portfolio: Fresenius said the agreement takes it from 29 marketed and pipeline molecules today to up to 66, addressing more than €370 billion in originator list-price-based-sales.
Technologies: monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins.
payment: a fee for service to WuXi Biologics for each biosimilar candidate that Fresenius selects for development.
Rights: Fresenius said it holds exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product under the agreement.
Financing: the company said the agreement is funded from operating cash flow and requires no new financing.

The release does not state a total price, an upfront payment or a milestone figure, so none is reported here.

Who does the development and manufacturing

Fresenius said development activities are expected to be conducted using WuXi Biologics' global network, which the release describes as spanning Europe, the United States, China and Singapore. WuXi Biologics is described as a contract organization for research, development and manufacturing.

Fresenius said it determines the long-term manufacturing strategy for each candidate, including the potential progressive transfer of selected products to mAbxience. The release says Fresenius has wholly owned mAbxience since October 2026 and points to its 1 October 2026 announcement of the acquisition of the remaining 45% of mAbxience.

For sponsors and trial teams, the release describes the structure: candidates are selected one at a time. Fresenius said development programs are selected against its criteria of market attractiveness, development risk and expected returns, and that research and development investment scales as selected programs progress.

What the company says about its financials

Fresenius said its full-year 2026 guidance remains unchanged. It said the agreement is additive to its 2030 Biopharma ambition, announced in December 2025, of approximately doubling Biopharma revenue compared with 2025 at an EBIT margin of around 20%, which relates to the existing marketed and late-stage portfolio. These are the company's statements about its own plans.

Michael Sen, Chief Executive Officer of Fresenius, is quoted in the release: "We are doubling down on our Biopharma business."