Samsung Bioepis Partners With Teva on U.S. Biosimilars
Up to 420 million dollars in contract value covers two FDA-approved biosimilars, with U.S. launch timing not yet disclosed.
Updated on Nov. 3, 2026 in Biotech
Samsung Bioepis signed an agreement with Teva Pharmaceuticals International for U.S. commercialization of two approved biosimilars, Remsima (SB2) and Eticovo (SB4), with total contract value up to 420 million dollars. Samsung Bioepis will handle development, production and supply, while Teva handles U.S. sales. The products are already approved by the U.S. Food and Drug Administration, so this is a commercial deal rather than a pending regulatory development.
Why it matters
The deal extends an existing partnership in which the two companies already cooperate on Episcli sales in the U.S. and Opuviz sales in Canada. The contract size equals roughly 34% of Samsung Bioepis's consolidated sales last year, signaling how central U.S. biosimilar distribution has become to the company's revenue model.
The disclosed figures are contract values rather than product sales or clinical performance data. The 420 million dollar total combines an upfront payment of up to 75 million dollars, launch-linked milestones of up to 75 million dollars, and sales-linked milestones of up to 270 million dollars, while the source gives no performance comparison for the products themselves.
The players
Samsung Bioepis
The biosimilar subsidiary of Samsung Epis Holdings, which develops and manufactures biosimilar versions of established biologic medicines and already sells Episcli in the U.S. and Opuviz in Canada through Teva.
Teva Pharmaceuticals International
The Swiss subsidiary of Teva, a global generic and specialty drug company that will handle U.S. commercialization of the two biosimilars.
The details
Biosimilars are lower-cost versions of biologic drugs, which are large protein-based medicines made from living cells, and they are approved only after demonstrating similarity to an existing reference product. Under this agreement, Samsung Bioepis, the biosimilar unit of Samsung Epis Holdings, keeps responsibility for developing, manufacturing and supplying the products, while Teva Pharmaceuticals International, the Swiss subsidiary of Teva, takes over U.S. sales. Payments are structured in tranches, with an upfront portion, milestones tied to additional launches, and milestones tied to cumulative sales targets.
Timeline
November 3, 2026: Samsung Epis Holdings disclosed the partnership agreement through its subsidiary Samsung Bioepis.
Within 30 days of the contract's effective date: 50 million dollars of the upfront payment is scheduled to be received.
The Tech Race
The agreement places Samsung Bioepis's Remsima and Eticovo against the originator biologics Remicade and Enbrel in the U.S. market, continuing a biosimilar competition that already includes the company's existing Episcli and Opuviz collaborations with Teva. It positions Samsung Bioepis as a supplier of multiple biosimilar products commercialized through a single distribution partner.
The deal does not change availability for patients today, since the products are already approved and no launch date or U.S. pricing was disclosed in the source. Patients and prescribers would see these biosimilars in the U.S. only once Teva begins sales, and the source does not specify that timeline.
The takeaway
The contract's sales-linked milestones, worth up to 270 million dollars, make its economics depend on how well the two biosimilars perform in the U.S. market. Watch for Teva's U.S. launch announcement and any subsequent disclosure of sales milestones achieved.
Further reading
For broader context on how these lower-cost biologic alternatives are developed and approved, see the Biotech section.
