Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. today announced that they have entered into a license and commercialization agreement for two FDA-approved immunology biosimilars: infliximab-abda, a biosimilar to Remicade®1 (infliximab) and ETICOVO® (etanercept-ykro), a biosimilar to Enbrel®2 (etanercept).

Under the terms of the agreement, Teva will obtain U.S. commercialization rights to etanercept-ykro at closing, while U.S. commercialization rights to infliximab-abda will transfer to Teva in Q3 2027. The timing of Teva’s future U.S. commercialization of etanercept-ykro will be announced at a later date. Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the end of 2026.

“This agreement strengthens our collaboration with Samsung Bioepis and will expand our U.S. immunology portfolio with two additional biologic treatment options,” said Richard Francis, President and CEO of Teva. “Biosimilars are an important part of our Pivot to Growth strategy, helping us build a stronger portfolio while expanding access to high-quality medicines. Together, we have an opportunity to bring more treatment choices to patients living with chronic inflammatory conditions.”

“We are delighted to expand our strategic alliance with Teva to strengthen the commercial footprint of our immunology portfolio in the U.S.,” said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. “Infliximab-abda has established a proven track record of clinical efficacy and supply reliability since its launch, while ETICOVO® represents an FDA-approved therapy poised to broaden treatment choices for patients. By pairing our dedication to high-quality biologic development and manufacturing with Teva's commercial reach across U.S. healthcare channels, we aim to ensure uninterrupted treatment continuity for existing patients and bring sustainable value to the U.S. healthcare system.”

Under the terms of the agreement and subject to certain conditions, Teva will pay Samsung Bioepis an upfront payment over the next 3 years. Samsung Bioepis may be eligible for additional launch and sales milestones payments. Teva and Samsung Bioepis will share profit from the commercialization of these products.

The agreement builds on a series of biosimilar collaborations between Teva and Samsung Bioepis. In 2025, the companies announced a U.S. agreement for EPYSQLI® (eculizumab-aagh), a biosimilar to Soliris®3 (eculizumab). In 2026, the companies announced two agreements, including one for OPUVIZ® (aflibercept) in Canada and a separate global agreement to license, develop and commercialize up to six potential biosimilar candidates currently in early-stage development, including biosimilar candidates referencing Fasenra®4 (benralizumab) and Ilaris®5 (canakinumab).

 

Source: tevapharm.com

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