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    Home > Active Ingredient News > Drugs Articles > Johnson is in danger! FDA accepts listing application of biosimilars of REMICADE

    Johnson is in danger! FDA accepts listing application of biosimilars of REMICADE

    • Last Update: 2016-05-26
    • Source: Internet
    • Author: User
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    Source: Biovalley 2016-05-25 US pharmaceutical giant Merck & Co recently announced that FDA has accepted the biological product license application (BLA) of biological generic SB2 (infliximab) submitted by partner Samsung bioepis (Samsung bioepis) The drug is a bio generic of REMICADE (generic name: infliximab) REMICADE is the best-selling anti-inflammatory drug in the world, with global sales of 9.24 billion US dollars in 2014 This BLA is the first bio generic drug BLA submitted by both parties in the U.S market Its purpose is to seek FDA approval for all currently approved treatment indications of REMICADE MSD said that FDA's acceptance of SB2's BLA is an exciting milestone in the cooperation between the company and Samsung bioepis in the field of bio generic drugs If approved, SB2 will provide an important treatment option that will help meet the needs of U.S doctors, patients, and healthcare systems for low-cost, high-quality biosimilars Samsung bioepis is a joint venture company established in 2012 by Samsung biologics, a subsidiary of SamSung group, a Korean electronics giant, and Biogen, a US biotechnology giant It is committed to the research and development of high-quality bio generic drugs, of which Samsung biologics holds 85% In 2013, Merck and Samsung bioepis reached a cooperation Currently, the bio generic drugs developed by the two sides cover immunology, oncology and diabetes Five products are in phase III clinical, including: SB2 (REMICADE, Leke), Sb3 (Herceptin, Herceptin), Sb4 (Enbrel, enli), sb5 (Humira, Sumeria), SB9 (Lantus, Laishi) The two sides have planned to submit all five biosimilars' listing applications to the global regulatory authorities in 2015-2016.
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