Teva Pharmaceuticals International GmbH agreed to commercialize two Samsung Bioepis Co., Ltd. biosimilars in the United States, with upfront and milestone payments to Samsung Bioepis capped at $420 million, a filing shows.
The filing lists up to $75 million upfront, up to $75 million tied to launch milestones and up to $270 million linked to sales milestones. Samsung Bioepis expects to receive $50 million within 30 calendar days after the agreement takes effect; the remaining $25 million of the upfront amount depends on contractual conditions. The $420 million covers upfront and milestone payments, while the filing describes profit sharing separately.
The medicines are Renflexis (infliximab-abda), which references Remicade, and ETICOVO (etanercept-ykro), which references Enbrel. U.S. Food and Drug Administration records show the products were approved in 2017 and 2019, respectively. The FDA says a biosimilar must closely resemble its reference medicine, without meaningful clinical differences in safety or effectiveness.
Teva is to receive ETICOVO’s U.S. commercial rights when the transaction closes. Renflexis rights are scheduled to transfer in the third quarter of 2027. Samsung Bioepis will continue manufacturing the products and overseeing regulatory matters, and the companies will share commercialization profits. Samsung Bioepis President and CEO Kyung-Ah Kim said the company aims to maintain treatment continuity for existing patients.
The companies said ETICOVO is not currently available in the United States. The FDA record marks its listed presentations “Disc,” and the announcement gives no U.S. launch date for the product.
The companies expect the deal to close by the end of 2026, subject to regulatory approvals and other conditions. The agreement builds on their existing biosimilar work: they announced a U.S. partnership for EPYSQLI in 2025 and an agreement in 2026 covering up to six early-stage biosimilar candidates.
