Teva and Samsung Bioepis Commercialize Two FDA-Approved Biosimilars in the U.S.

Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. have announced a licensing and commercialization agreement for two FDA-approved immunology biosimilars. The biosimilars in question are infliximab-abda, a biosimilar to Remicade, and ETICOVO, a biosimilar to Enbrel. Teva will secure commercialization rights for enalizumab-ykro upon completion of the transaction, while Teva will acquire commercialization rights for infliximab-abda beginning in Q3 2027.

Samsung Bioepis will retain responsibility for regulation and manufacturing of both products. The deal is pending customary closing conditions and is anticipated to conclude by the end of 2026. This partnership aims to bolster Teva's U.S. immunology portfolio with two additional biologic treatment options, in line with Teva's Pivot to Growth strategy.

Samsung Bioepis' President and CEO, Kyung-Ah Kim, expressed enthusiasm for the strategic alliance, highlighting the proven efficacy and supply reliability of infliximab-abda, as well as the potential of ETICOVO to broaden treatment choices for patients with chronic inflammatory conditions. Under the terms of the agreement, Teva will pay Samsung Bioepis an upfront fee over the next three years, with the possibility of additional payments based on launch and sales milestones.

Both companies will share profits from the commercialization of the biosimilars. This agreement follows a series of biosimilar collaborations between Teva and Samsung Bioepis, including agreements for EPYSQLI, OPUVIZ, and the potential development and commercialization of up to six biosimilar candidates in early-stage development.

These biosimilars target tumor necrosis factor (TNF) inhibitors for treating chronic inflammatory and autoimmune conditions.