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FDA approves Amgen's Humira biosimilar AMJEVITA for treatment of seven inflammatory diseases

FDA approved Amgen's Humira biosimilar AMJEVITA™ for treatment of seven inflammatory diseases. Published at Amgen's News releases...

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New data on three Anti-TNF-α bosimilar molecules, Benepali (etanercept), Flixabi (infliximab) and SB5...

 Phase III studies for Benepali®, Flixabi® and SB5, respectively, demonstrated comparable efficacy and safety profiles after...

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a...

a biosimilar version of Remicade (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis,...

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Benepali – a biosimilar version of Enbrel (etanercept) has received a positive opinion from EMA's Committee...

The CHMP’s positive opinion was based on a robust preclinical and clinical data package submitted to the EMA by Samsung Bioepis. The data in...

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Merck and Samsung Bioepis Announced the Approval of BRENZYS (Etanercept), a Biosimilar of Enbrel, in Korea

Merck, known as MSD outside the United States and Canada, in partnership with Samsung Bioepis Co.have announced the approval of BRENZYS®...

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Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil.

ANVISA Approves First Infliximab Biosimilar in Brazil

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