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Teva and Samsung Bioepis signed a license and commercialization agreement for two FDA-approved immunology biosimilars, expanding Teva’s planned U.S. portfolio of treatments for chronic inflammatory and autoimmune conditions. The companies announced the agreement Tuesday, November 3; the transaction has not closed.
Under the company announcement, Teva will obtain U.S. commercialization rights to Eticovo, or etanercept-ykro, at closing. Rights to infliximab-abda will transfer in the third quarter of 2027. The companies expect closing by the end of 2026, subject to customary conditions, including necessary regulatory approvals.
The timing of Teva’s U.S. commercialization of Eticovo will be announced later. Although the FDA approved it in 2019, the product is not currently available on the U.S. market, the companies said. Approval, transfer of commercial rights and an actual product launch are separate milestones.
Samsung Bioepis will continue to handle regulatory oversight and manufacturing of both medicines. Teva will make an upfront payment over the next three years, subject to certain conditions, and Samsung Bioepis may receive additional launch and sales milestone payments. The companies will share commercialization profit; their release did not disclose the payment amounts.
Both products inhibit tumor necrosis factor, a protein involved in inflammation. Infliximab-abda is a biosimilar to Remicade and was FDA-approved in 2017. Its approved uses include Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
Eticovo is a biosimilar to Enbrel. Its approved uses include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged two and older, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis in patients aged four and older. The products have distinct approved indications; the agreement is not a new FDA approval for either medicine.
The deal extends earlier collaborations between the companies, including a 2025 U.S. agreement for Epysqli and 2026 agreements covering Opuviz in Canada and up to six early-stage biosimilar candidates globally. Those development programmes are separate from the two already approved products covered by Tuesday’s agreement.
JBizNews Desk | Tel Aviv, Israel
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