Teva will gain U.S. rights to two approved Samsung Bioepis biosimilars in a profit-sharing deal expected to close by the end of 2026.
Teva Pharmaceutical Industries and Samsung Bioepis have signed a license and commercialization agreement that would give Teva U.S. rights to two approved immunology biosimilars, infliximab-abda and etanercept-ykro, the companies announced Nov. 3.1 Samsung Bioepis would keep manufacturing and regulatory oversight while Teva would take over sales, with closing anticipated by the end of 2026.1
“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.1
Francis tied the deal to Teva’s Pivot to Growth strategy, under which the company is building a larger biosimilar portfolio.1
Teva will obtain U.S. commercialization rights to etanercept-ykro at closing, while rights to infliximab-abda transfer in the third quarter of 2027.1 The timing of Teva’s U.S. launch of etanercept-ykro will be announced later.1
Teva will pay Samsung Bioepis an upfront amount over three years, and the Korean company may receive additional launch and sales milestone payments. The companies will share profit from sales.1
The release does not disclose payment amounts, and closing remains subject to customary conditions, including regulatory approvals.1 A share-price reaction to the announcement could not be verified at the time of writing.
Kyung-Ah Kim, president and CEO of Samsung Bioepis, said: “We are delighted to expand our strategic alliance with Teva to strengthen the commercial footprint of our immunology portfolio in the U.S.”1
Both products are inhibitors of tumor necrosis factor indicated for chronic inflammatory and autoimmune conditions.1 Infliximab-abda, a biosimilar to Remicade (infliximab), received FDA approval in 2017 for indications that include Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA) in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis (PsA), and plaque psoriasis.1
Merck introduced the product in the United States in July 2017 under an earlier global agreement with Samsung Bioepis.2 The release does not identify who currently distributes it, and Teva will newly assume commercialization in 2027.1
Etanercept-ykro, a biosimilar to Enbrel (etanercept), was approved by FDA in 2019 for RA, polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, PsA, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years and older. It is not currently marketed in the U.S.1
In a phase 3 randomized trial of 596 patients with RA despite methotrexate therapy, response rates at week 24 were 78.1% with etanercept-ykro and 80.3% with the reference product, and the difference fell within the prespecified equivalence margin. Antidrug antibodies were detected in 0.7% and 13.1% of patients, respectively.3
Both products carry boxed warnings for serious infections and malignancies, according to the release.1
The companies announced a U.S. agreement in January 2025 for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab). Samsung Bioepis handles development, manufacturing and supply under that arrangement, while Teva commercializes the product.4
In 2026, the companies announced two further agreements: one for Opuviz (aflibercept) in Canada and a global agreement to license, develop and commercialize up to six early-stage biosimilar candidates, including candidates referencing Fasenra (benralizumab) and Ilaris (canakinumab).1 The latest deal keeps the same division of labor, although these two products are already approved rather than in development.
Several details remain undisclosed. The release does not state the size of the upfront payment, the milestone amounts or why etanercept-ykro is not yet on the U.S. market.1
Nor does it describe how patients and prescribers using infliximab-abda will experience the shift in commercial responsibility, beyond Kim’s statement that the companies aim “to ensure uninterrupted treatment continuity for existing patients.”1
The release also does not address pricing, payer coverage, or competitive positioning, all of which would shape uptake of either product. Independent clinical or commercial analysis of these products under Teva was not available at the time of writing.
