Merck, Samsung Advance Biosimilars

Merck & Co. Inc. and Samsung Bioepis Co., Ltd. are advancing SB4, an investigational biosimilar of Enbrel (etanercept), and SB2, an investigational biosimilar of Remicade (infliximab). In a Phase III clinical study, both met their primary endpoints, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.

Merck and Samsung Bioepis announced in February 2013 a collaboration to develop and commercialize in certain partnered territories multiple biosimilar candidates. In February 2014, the two companies expanded the collaboration to include MK-1293, an insulin glargine biosimilar candidate currently in Phase III clinical development for the treatment of patients with Type 1 and Type 2 diabetes. Under the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development, manufacturing, clinical trials and regulatory registration, except for MK-1293, which Merck will continue to develop and manufacture. Merck will be responsible in its partnered territories for commercialization of all approved products resulting from the collaboration.

The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase III development [Merck partnered territories]: SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]; SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]; SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]; SB3 Herceptin (trastuzumab) [worldwide]; and MK-1293 Lantus (insulin glargine) [worldwide] Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016.

Samsung Bioepis is also partnered with Biogen for developing anti-TNF biosimilars.

Source: Merck & Co. Inc.

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