• Regulatory NewsRegulatory News

    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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    Woodcock: FDA Needs More Funds for Biosimilar Review Program

    Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s (FDA) CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program. When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, FDA received no additional congressional appropriations to run the program, Woodcock said, fo...
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    FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody

    South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the US Food and Drug Administration (FDA) for Remsima, its biosimilar version of Jannsen's Remicade (infliximab). The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar pathway, and reportedly the first-ever monoclonal antibody (mAb) to seek approval through the pathway. The first biosimilar filing for ...