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Samsung Bioepis & Teva Enter US$420m Commercialisation Deal for Etanercept and Infliximab Biosimilars in US

Nov 3, 2026

On 3 November 2026, Samsung Bioepis and Teva announced they have entered a licence and commercialisation agreement for Eticovo®, biosimilar to Immunex/Amgen’s Enbrel® (etanercept), and Renflexis®, biosimilar to Janssen’s Remicade® (infliximab).  According to a regulatory filing by Samsung Bioepis, the deal is worth up to 563.2 billion won (US$420 million).

Under the terms of the agreement, Teva will obtain US commercialisation rights to Eticovo® at closing (anticipated by the end of 2026), while the US commercialisation rights to biosimilar infliximab will transfer to Teva in Q3/2027.  Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products.

Subject to certain conditions, Teva will pay Samsung Bioepis an upfront payment over the next 3 years.  Samsung Bioepis may also be eligible for additional launch and sales milestone payments.  Teva and Samsung Bioepis will share the profits from the commercialisation of the biosimilars.

Samsung Bioepis’ Eticovo® was approved by the FDA in April 2019.  Samsung Bioepis is prevented from launching Eticovo® in the US until 2029 by a permanent injunction granted by the US District Court for the District of New Jersey in November 2021.  Samsung Bioepis’ Renflexis® (infliximab-abda) was approved in the US in April 2017.

Teva and Samsung Bioepis first entered into a strategic partnership in January 2025 for the US-commercialisation of Samsung Bioepis’ Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®.  In July 2026, that agreement was expanded to include the commercialisation of Samsung Bioepis’ Opuviz® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, in Canada.

On 1 October 2026, Samsung Bioepis and Teva announced a global collaboration and licence agreement for the US, Canada and Europe, to expand their existing partnership for up to six additional biosimilars, including SB44, biosimilar to Novartis’ Ilaris® (canakinumab), and SB41, biosimilar to AstraZeneca’s Fasenra® (benralizumab), plus four other undisclosed early-stage biosimilars.