Merck & Co., Samsung Bioepis Receive Korean OK for Biosimilar

Merck & Co. Inc. and Samsung Bioepis Co., Ltd. have received approval of Renflexis (infliximab), a biosimilar of the immunology medicine, Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. Merck will commercialize Samsung Bioepis' Renflexis in Korea as part of Merck's commercialization partnership with Samsung Bioepis in biosimilars.

Samsung Bioepis' Renflexis is indicated in Korea for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis in adult patients (age 18 years and older). Merck plans to launch the product in South Korea in the first half of 2016.

Merck and Samsung Bioepis announced in February 2013 a development and commercialization agreement under which Merck will commercialize multiple biosimilar candidates in certain partnered territories. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Under a separate development and commercialization agreement with Samsung Bioepis announced in February 2014, Merck is responsible for the development, registration, manufacturing and commercialization of MK-1293 (insulin glargine) worldwide.

Merck will be responsible in its partnered territories for commercialization of the following biosimilar candidates in immunology, oncology and diabetes [Merck partnered territories]: SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]; SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]; SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]; SB3 Herceptin (trastuzumab) [worldwide]; and MK-1293 Lantus (insulin glargine) [worldwide].

Source: Merck KGaA

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