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(서울=뉴스1) 임여익 기자 = Samsung Bioepis has inked a commercialization deal with global pharmaceutical giant Teva, potentially worth up to 563.2 billion KRW (about 420 million USD). The partnership aims to boost U.S. sales of two autoimmune disease treatments and strengthen their North American collaboration.
On Tuesday, Samsung Bioepis disclosed a commercial partnership agreement with Teva Pharmaceuticals International for the U.S. market distribution of its autoimmune disease therapies, Renflexis (infliximab) and Eticovo (etanercept).
The agreement's total value could reach 420 million USD. This includes an upfront payment of up to 75 million USD and potential milestone payments of up to 345 million USD tied to product launches and sales performance.
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Under the terms, Samsung Bioepis will oversee product development, manufacturing, and supply, while Teva will handle U.S. market sales. The companies will share profits from commercialization based on predetermined contract terms.
Renflexis, a biosimilar to Janssen's Remicade, treats conditions like Crohn's disease, ulcerative colitis, and rheumatoid arthritis. Eticovo, a biosimilar to Amgen's Enbrel, is used for rheumatoid arthritis, psoriatic arthritis, and psoriasis. Both products have secured U.S. Food and Drug Administration (FDA) approval.
Renflexis, approved by the FDA in April 2017, was among Samsung Bioepis' first biosimilars to enter the U.S. market.
Eticovo received FDA approval in April 2019.
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This new agreement expands Samsung Bioepis' U.S. commercialization efforts for these two approved autoimmune disease treatments.
Samsung Bioepis and Teva have a history of collaboration in North America. They currently partner on U.S. sales of Epclusa, a biosimilar to Soliris for paroxysmal nocturnal hemoglobinuria, and Canadian sales of Opuviz, an Eylea biosimilar for ophthalmic conditions.
The agreement was finalized on Monday, U.S. Eastern Time. Of the upfront payment, 50 million USD is due within 30 days of the contract's effective date, with the remaining 25 million USD contingent on meeting specific conditions. The contract's duration and detailed terms remain undisclosed.
This article was originally written in Korean by News1 reporters, translated with AI, and reviewed by editors.
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