Teva and Samsung Bioepis Expand Partnership for Up to Six Biosimilars

Teva Pharmaceutical Industries and Samsung Bioepis announced a global agreement on October 1 to develop, register, manufacture, and commercialize up to six potential biosimilar candidates. The pact pairs Samsung Bioepis’ development and manufacturing operations with Teva’s worldwide commercial footprint spanning the United States, Europe, and Canada. Samsung Bioepis is a wholly owned subsidiary of Samsung Epis Holdings.

Samsung Bioepis and Teva Partner on Biosimilars

The expanded partnership brings two specific investigational programs into public view alongside four unassigned options. The collaboration covers SB41, a proposed biosimilar referencing AstraZeneca’s immunology drug Fasenra, and SB44, a proposed biosimilar referencing Novartis’ periodic fever and Still’s disease treatment Ilaris. Samsung Bioepis assumes responsibility for development, regulatory registration, and manufacturing. Teva manages commercialization duties across the U.S., Europe, and Canada, while retaining an option to expand the arrangement into additional territories.

Neither SB41 nor SB44 received a specific clinical development stage in the initial company announcements. Financial terms of the multi-product pact remain undisclosed. Legal advisers involved in the transaction included a Ropes & Gray team comprising life sciences licensing partner Abby Gregor and associate Zach Kramer, who advised Teva Pharmaceutical Industries.

Foundation in Earlier Commercial Launches

This global agreement builds directly on prior collaborations between the two firms. The partnership already delivered EPYSQLI, an FDA-approved biosimilar referencing Soliris for certain blood conditions, in the U.S. market. The partners subsequently expanded that earlier framework to include OPUVIZ, an aflibercept biosimilar referencing Eylea in Canada.

Executive leadership framed the new multi-product deal as a pillar of ongoing corporate strategy. Richard Francis, President and CEO of Teva, stated in the release that biosimilars are an increasingly important part of the company’s Pivot to Growth strategy and its ambition to transform into a leading biopharmaceutical company. Kyung-Ah Kim, President and CEO of Samsung Bioepis, noted that the agreement marks another milestone in the shared journey to improve patient access to life-changing medicines.

Broader Industry Dynamics

The October 1 announcement arrives amid a string of high-ambition biosimilar agreements across the pharmaceutical sector. Developers are racing to capitalize on an approaching patent cliff for lucrative branded biologics. Samsung Bioepis previously lined up a multi-product agreement with Sandoz in March to partner on up to five biosimilars, beginning with SB36 referencing Takeda’s Entyvio.

At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world, Kyung-Ah Kim added.