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Teva and Samsung Bioepis to commercialise two FDA-approved biosimilars in the US

Teva will get US commercialisation rights for Eticovo upon close and infliximab in Q3 2027
- PMLiVE

Teva and Samsung Bioepis have announced that they have entered into a license and commercialisation agreement for two FDA-approved immunology biosimilars: infliximab, a biosimilar to Remicade (infliximab) and Eticovo (etanercept), a biosimilar to Enbrel (etanercept).

Under the terms of the agreement, Teva will obtain US commercialisation rights to etanercept at closing, while US commercialisation rights to infliximab will transfer to Teva in Q3 2027. The timing of Teva’s future US commercialisation of etanercept 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 US 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 US,” said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. “Infliximab 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. ”

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

The agreement builds on a series of biosimilar collaborations between Teva and Samsung Bioepis. In 2025, the companies announced a US agreement for Epysqli (eculizumab), a biosimilar to Soliris (eculizumab). In 2026, the companies announced two agreements, including one for Opuviz (aflibercept) in Canada and a separate global agreement to license, develop and commercialise up to six potential biosimilar candidates currently in early-stage development, including biosimilar candidates referencing Fasenra (benralizumab) and Ilaris (canakinumab).

PMGroup
9th November 2026
From: Sales
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