Teva secures US commercialisation rights to two Samsung Bioepis immunology biosimilars in deal worth up to $420 million
Teva has secured US commercialisation rights to two FDA-approved Samsung Bioepis immunology biosimilars under an agreement worth up to $420 million, expanding its specialty biologics portfolio.
The agreement announced on 3 November 2026 covers infliximab-abda, a biosimilar referencing Remicade, and ETICOVO (etanercept-ykro), referencing Enbrel, with Teva committing $50 million upfront subject to conditions and up to $370 million in additional launch and commercial milestones.
Samsung Bioepis will retain manufacturing and regulatory responsibilities while the partners share commercial profits, with ETICOVO rights expected to transfer at closing by year-end 2026 and infliximab-abda rights scheduled to transfer in the third quarter of 2027; both products were previously FDA-approved, making this a commercialisation transaction rather than a new regulatory approval.
Field | Content |
Article Type | Deals |
Company | Teva Pharmaceutical Industries |
Partner | Samsung Bioepis |
Deal Type | US biosimilar licence and commercialisation agreement |
Announcement Date | 3 November 2026 |
Transaction Status | Agreement announced; rights transfers pending |
Products Covered | Two FDA-approved immunology biosimilars |
Product 1 | Infliximab-abda |
Product 1 Reference Medicine | Remicade |
Product 2 | ETICOVO (etanercept-ykro) |
Product 2 Reference Medicine | Enbrel |
Therapeutic Area | Immunology; inflammatory and autoimmune diseases |
Modality | Biosimilar monoclonal antibody and fusion protein therapeutics |
Maximum Potential Deal Value | $420 million |
Upfront Payment | $50 million subject to conditions |
Additional Milestones | Up to $370 million in launch and commercial milestones |
Profit-Sharing Structure | Commercial profits shared between Teva and Samsung Bioepis |
Commercialisation Responsibilities | Teva receives US commercialisation rights |
Manufacturing Responsibilities | Samsung Bioepis retains manufacturing responsibilities |
Regulatory Responsibilities | Samsung Bioepis retains regulatory responsibilities |
ETICOVO Rights Transfer | At closing; expected by the end of 2026 |
Infliximab-abda Rights Transfer | Third quarter of 2027 |
Previous FDA Approval Years | Infliximab-abda: 2017; ETICOVO: 2019 |
Geographic Scope | United States |
Regulatory Status | Both biosimilars previously FDA-approved; no new approvals announced |
What Happened | Teva and Samsung Bioepis entered an agreement granting Teva US commercialisation rights to two existing immunology biosimilars. |
Why It Matters | The transaction strengthens Teva's US biosimilar portfolio and creates additional commercial opportunities in established immunology markets. |
Strategic Rationale | Combine Samsung Bioepis' manufacturing and regulatory capabilities with Teva's US commercial infrastructure. |
Transaction Distinction | Separate from the companies' previously announced six-candidate biosimilar development collaboration. |
Key Takeaway | Teva has agreed to pay up to $420 million for US commercialisation rights, comprising $50 million upfront and up to $370 million in contingent milestones. |
What to Watch | Closing conditions, rights transfers, US launch plans, formulary access, commercial uptake and milestone achievement. |
Primary Source | Teva Pharmaceutical Industries |
Primary Source URL | https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-and-Samsung-Bioepis-Announce-Agreement-to-Commercialize-Two-FDA-Approved-Biosimilars-in-the-U-S-/default.aspx |
Relevant Date | 3 November 2026 |
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