Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced on November 3, 2026, that they have entered into a license and commercialization agreement covering two FDA-approved immunology biosimilars: infliximab-abda, a biosimilar to Remicade (infliximab), and ETICOVO (etanercept-ykro), a biosimilar to Enbrel (etanercept).

The announcement was made jointly from Tel Aviv, Israel, and Incheon, South Korea.

Teva to Gain U.S. Commercialization Rights for Two Biosimilars

Under the terms of the agreement, Teva will obtain U.S. 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 U.S. commercialization of etanercept-ykro will be announced at a later date. Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products.

The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the end of 2026.

Financial Terms of the Agreement

Under the agreement and subject to certain conditions, Teva will pay Samsung Bioepis an upfront payment over the next three years. Samsung Bioepis may also be eligible for additional launch and sales milestone payments.

The two companies will share profit from the commercialization of the products.

Leadership Commentary

Richard Francis, President and CEO of Teva, said the agreement strengthens the company's collaboration with Samsung Bioepis and will expand its U.S. immunology portfolio with two additional biologic treatment options.

According to Francis, biosimilars are an important part of Teva's Pivot to Growth strategy, helping build a stronger portfolio while expanding access to high-quality medicines. He noted that together the companies have an opportunity to bring more treatment choices to patients living with chronic inflammatory conditions.

Kyung-Ah Kim, President and CEO of Samsung Bioepis, said the company is delighted to expand its strategic alliance with Teva to strengthen the commercial footprint of its immunology portfolio in the U.S. Kim stated that infliximab-abda has established a proven track record of clinical efficacy and supply reliability since its launch, while ETICOVO represents an FDA-approved therapy poised to broaden treatment choices for patients.

By pairing Samsung Bioepis' dedication to high-quality biologic development and manufacturing with Teva's commercial reach across U.S. healthcare channels, the company aims to ensure uninterrupted treatment continuity for existing patients and bring sustainable value to the U.S. healthcare system.

About the Two Biosimilars

Both biosimilars are tumor necrosis factor (TNF) inhibitors indicated for the treatment of chronic inflammatory and autoimmune conditions.

Infliximab-abda was approved by the FDA in 2017 for indications including Crohn's disease in adult and pediatric patients, ulcerative colitis in adult and pediatric patients, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Teva will newly assume commercialization of the product, with the transfer scheduled to take effect in the third quarter of 2027.

Etanercept-ykro was approved by the FDA in 2019 and is not currently available on the U.S. market. It is approved for indications including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged two years and older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged four years and older.

Infliximab-abda Safety Information Highlights Serious Infection Risks

According to the safety information provided for infliximab-abda, patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Reported infections include active tuberculosis, including reactivation of latent tuberculosis, and invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis.

Patients should be tested for latent tuberculosis before use and during therapy, and treatment for latent infection should be initiated prior to use. Infliximab-abda should be discontinued if a patient develops a serious infection or sepsis.

Building on a Series of Collaborations

The agreement builds on a series of biosimilar collaborations between Teva and Samsung Bioepis. In 2025, the companies announced a U.S. agreement for EPYSQLI (eculizumab-aagh), a biosimilar to Soliris (eculizumab).

In 2026, the companies announced two additional agreements: one for OPUVIZ (aflibercept) in Canada and a separate global agreement to license, develop, and commercialize up to six potential biosimilar candidates currently in early-stage development, including biosimilar candidates referencing Fasenra (benralizumab) and Ilaris (canakinumab).

Teva described the latest transaction as an expansion of its collaboration with Samsung Bioepis, strengthening its generics powerhouse and biosimilars portfolio as part of its Pivot to Growth strategy. Teva shares trade on both the NYSE and TASE under the ticker TEVA.

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