Teva Strengthens U.S. Biosimilar Portfolio Through Samsung Bioepis Deal

Teva Pharmaceutical has expanded its U.S. immunology portfolio through a commercialization agreement with Samsung Bioepis covering two FDA-approved TNF inhibitor biosimilars. The agreement gives Teva rights to ETICOVO (etanercept-ykro) at closing and infliximab-abda in the third quarter of 2027, strengthening its position in the competitive U.S. biosimilars market.

Under the agreement, Teva will obtain U.S. commercialization rights to ETICOVO, a biosimilar referencing Enbrel (etanercept), upon transaction closing. However, the company has not yet announced when it plans to launch the product in the United States.

Commercialization rights to infliximab-abda, a biosimilar referencing Remicade (infliximab), will transfer to Teva in Q3 2027. The transaction is expected to close by the end of 2026, subject to customary closing conditions and necessary regulatory approvals.

Samsung Bioepis will retain responsibility for manufacturing and regulatory oversight of both products. This arrangement allows the South Korean biotechnology company to maintain control over product supply and regulatory activities while Teva takes responsibility for U.S. commercial operations.

The financial terms include upfront payments from Teva to Samsung Bioepis over three years, with additional launch and sales milestone payments subject to certain conditions. The companies will also share profits generated through commercialization.

Clinical and Regulatory Profiles of the Two Biosimilars

Both products target tumor necrosis factor (TNF), a key inflammatory signaling protein involved in several autoimmune and chronic inflammatory disorders. By inhibiting TNF activity, these therapies reduce inflammation and control disease progression.

• Infliximab-abda: Received FDA approval in 2017. It is indicated for adult and pediatric Crohn’s disease and ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Its established regulatory approval and clinical use provide Teva with an opportunity to enter an existing biosimilar market with an approved product rather than undertaking an entirely new development programme. Samsung Bioepis has also highlighted the product’s established clinical efficacy and supply reliability.
• ETICOVO (etanercept-ykro): Received FDA approval in 2019 but is not currently marketed in the United States. Its approved indications include 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. Its approval provides a regulatory foundation for future U.S. commercialization, although its market entry timeline remains undecided. The timing will be particularly relevant in determining how Teva positions the product against existing etanercept biosimilar competition.

Expanded Partnership Strengthens Teva’s Biosimilar Strategy

The agreement extends an existing collaboration between the companies as Teva advances its Pivot to Growth strategy, which includes expanding its biosimilars business alongside its established generics operations.

Their previous agreements include U.S. commercialization rights for EPYSQLI (eculizumab-aagh), a biosimilar referencing Soliris, announced in 2025. In 2026, the companies also entered an agreement covering OPUVIZ (aflibercept) in Canada and a separate global collaboration to license, develop, and commercialize up to six early-stage biosimilar candidates, including products referencing Fasenra (benralizumab) and Ilaris (canakinumab).

Teva CEO Richard Francis said the agreement would broaden the company’s U.S. immunology portfolio and expand treatment options for patients with chronic inflammatory conditions. Samsung Bioepis CEO Kyung-Ah Kim highlighted the combination of the company’s biologics development and manufacturing capabilities with Teva’s established U.S. commercial network.

Commercialization Timelines Will Determine Market Impact

The agreement provides Teva with access to two FDA-approved immunology biosimilars without assuming their manufacturing and regulatory responsibilities. However, their commercial prospects will depend on launch timing, pricing, market access, and competition from existing biologic and biosimilar therapies.

Infliximab-abda is scheduled to transfer to Teva in Q3 2027, while ETICOVO’s future U.S. launch date remains unannounced. The transaction therefore expands Teva’s commercial pipeline immediately at the agreement level, but the contribution of both products to its U.S. biosimilar business will become clearer as commercialization plans progress.

 Reference

Teva and Samsung Bioepis Announce Agreement to Commercialize Two FDA-Approved Biosimilars in the U.S., Teva Pharmaceutical, 03 November 2026