Teva Licenses US Rights to Samsung Bioepis TNF Inhibitor Biosimilars

Teva Pharmaceutical Industries and Samsung Bioepis announced on November 3, 2026, a license and commercialization agreement for 2 FDA-approved tumor necrosis factor (TNF) inhibitor biosimilars in the United States. They are infliximab-abda, a biosimilar to infliximab (Remicade), and etanercept-ykro (Eticovo), a biosimilar to etanercept (Enbrel).¹ Teva will obtain US commercialization rights to etanercept-ykro at closing and to infliximab-abda in the third quarter of 2027. Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products.¹

"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, in a company press release.¹

What are the terms of the agreement?

Teva will pay Samsung Bioepis an up-front payment over the next 3 years, subject to certain conditions, and Samsung Bioepis may be eligible for additional launch and sales milestone payments.¹ The companies will share profit from commercialization of the products.¹ Financial terms were not disclosed. The transaction is subject to customary closing conditions, including regulatory approvals, and is expected to close by the end of 2026.¹

What are the 2 biosimilars?

FDA approved infliximab-abda in 2017. Its indications include adult and pediatric Crohn disease and ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.¹ Teva will newly assume commercialization of the product in the third quarter of 2027.¹ Kyung-Ah Kim, PhD, president and CEO of Samsung Bioepis, said in the release that infliximab-abda has established a track record of clinical efficacy and supply reliability since its launch.¹

FDA approved etanercept-ykro in 2019, but the product is not currently available on the US market.¹ Its approved indications include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients 2 years and older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients 4 years and older.¹ Teva said the timing of its US commercialization of etanercept-ykro will be announced later.¹

Patent litigation has shaped US launches of etanercept biosimilars. In 2019, a federal court upheld 2 Amgen patents covering etanercept in a case against Sandoz. Sandoz's biosimilar had been FDA approved in 2016 but not launched, and Sandoz said the patents extended Amgen's US protection for etanercept to 2029.²

How does the deal fit the companies' biosimilar partnership?

The agreement builds on a series of collaborations between the companies.¹ In 2025, they announced a US agreement for eculizumab-aagh (Epysqli), a biosimilar to eculizumab (Soliris).¹ In October 2026, they agreed to develop up to 6 potential biosimilar candidates, including candidates referencing benralizumab (Fasenra) and canakinumab (Ilaris). Under that deal, Samsung Bioepis handles development, regulatory registration, and manufacturing, while Teva leads global commercialization, starting with the US, Europe, and Canada.³ The companies have also partnered on aflibercept (Opuviz) in Canada.¹

The deal comes as the US biosimilar market continues to expand. According to a Samsung Bioepis market report, 92 biosimilars across 20 unique biological molecules had been approved by FDA as of March 2026, and 67 (73%) had launched.⁴

What are the limitations?

The transaction has not closed and remains subject to regulatory approvals. The companies did not disclose the up-front payment amount, milestone values, or profit-sharing terms. No US launch date has been set for etanercept-ykro, and the announcement does not address the patent landscape for etanercept. The announcement also does not specify which Samsung Bioepis manufacturing sites will supply the products.

References

1. Teva Pharmaceutical Industries; Samsung Bioepis. Teva and Samsung Bioepis announce agreement to commercialize two FDA-approved biosimilars in the U.S. Press release. Published November 3, 2026. Accessed November 3, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-and-samsung-bioepis-announce-agreement-to-commercialize-two-fda-approved-biosimilars-in-the-u.s
2. Amgen wins Enbrel patent case, Sandoz to appeal ruling. BioPharm International. Published August 13, 2019. Accessed November 3, 2026. https://www.biopharminternational.com/view/amgen-wins-enbrel-patent-case-sandoz-appeal-ruling
3. Teva Pharmaceutical Industries. Samsung Bioepis and Teva expand strategic partnership to advance up to six potential biosimilar candidates. Press release. Published October 1, 2026. Accessed November 3, 2026. https://www.tevapharm.com/news-and-media/latest-news/samsung-bioepis-and-teva-expand-strategic-partnership-to-advance-up-to-six-potential-biosimilar-candidates/
4. Samsung Bioepis. Samsung Bioepis releases second quarter 2026 US biosimilar market report. Press release. Published April 27, 2026. Accessed November 3, 2026. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=551&currentPage=1