Teva and Samsung Bioepis have entered a license and commercialization agreement for two FDA-approved immunology biosimilars: infliximab-abda, a biosimilar to Remicade, and ETICOVO (etanercept-ykro), a biosimilar to Enbrel. Both are TNF inhibitors.
Teva will obtain US commercialization rights to etanercept-ykro at closing, while rights to infliximab-abda will transfer to Teva in the third quarter of 2027. The timing of Teva's future US commercialization of etanercept-ykro will be announced later. Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products. The transaction is subject to customary closing conditions, including regulatory approvals, and is expected to close by the end of 2026.
Under 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 milestone payments. The companies will share profit from commercialization.
Infliximab-abda was approved by the FDA in 2017 for indications including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Etanercept-ykro was approved in 2019 and is not currently available in the US market. It is approved for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
The deal builds on prior collaborations between the companies, including 2025 and 2026 agreements covering EPYSQLI, OPUVIZ and up to six early-stage biosimilar candidates.
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