Tag: biosimilar pipeline

Fresenius Kabi Expands Biosimilar Pipeline With Deal for Next-Generation Molecules

Joining forces with a Chinese biologics company enabled Fresenius Kabi to obtain rights up for up to 37 biosimilar candidates over the next decade.

Fresenius Kabi, a serious player in the US biosimilar arena, had been seeking ways to bolster its biosimilar pipeline, and it made quite a splash earlier this week. The company signed an agreement with the Chinese-based WuXi Biologics, vastly expanding the Fresenius Kabi biosimilar pipeline. This comes after completing its acquisition of another biosimilar manufacturer last month.

Fresenius Kabi

Through October 2026, Fresenius owned several biosimilar approvals: adalimumab (Idacio), denosumab (Conexxence/Bomyntra), pegfilgrastim (Stimufend), rituximab (Zimrixby), tocilizumab (Tyenne), and ustekinumab (Otulfi)). PB016, a vedolizumab biosimilar in the Fresenius Kabi biosimilar pipeline through a partnership with Polpharma) is currently in FDA review. It also has Opdivo and Keytruda biosimilar candidates in development, among others.

Adding to the Fresenius Kabi Biosimilar Pipeline

The new deal will provide “exclusive option rights for up to 37 potential first-to-market biosimilar candidates,” expanding Fresenius’ present portfolio from 29 marketed and pipeline molecules “to up to 66 in the next decade.” According to Fresenius, this will provide a “next-generation portfolio” that covers “13 therapeutic areas and multiple biologic technologies, including monoclonal and bispecific antibodies, antibody–drug conjugates, and fusion proteins.”

No monetary value was placed on the agreement, but Fresenius disclosed that it will pay WuXi Biologics on a “fee-for-service basis for each biosimilar candidate that Fresenius selects for development.”

Fresenius also announced that it had purchased the remaining shares of mAbxience in October, completing its full acquisition of the company. This move had also added to Fresenius’ biosimilar pipeline.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.