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    FDA modifies immunogenicity language in final bispecific antibody guidance

    A newly finalized guidance on bispecific antibodies from the US Food and Drug Administration (FDA) notes that although bispecific antibodies can generally be characterized in the same ways as standard monoclonal antibodies and manufacturing processes may be similar, some scientific and regulatory considerations are unique to bispecifics.   According to a 24 May agency announcement , while the regulatory pathway for evaluating monoclonal antibodies is “well established...
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    EMA reviewing data on four COVID monoclonal antibodies

    The European Medicines Agency (EMA) on Thursday announced its Committee for Medicinal Products for Human Use (CHMP) is reviewing data on the use of two monoclonal antibody combinations developed by Regeneron and Eli Lilly to treat patients with COVID-19 who are at high risk of progressing to severe disease but who do not require supplemental oxygen.   EMA says the committee will conduct two separate reviews, one of Regeneron’s antibody combination known as REGN-COV2 (c...
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    New Indication for Roche’s Actemra Means First FDA-Approved Drug to Treat Giant Cell Arteritis

    The US Food and Drug Administration (FDA) on Monday expanded the approved use of Roche’s Actemra (tocilizumab) to treat adults with giant cell arteritis, making it the first FDA-approved therapy for this condition. The efficacy and safety of subcutaneous (injected under the skin) Actemra for giant cell arteritis were established in a double-blind, placebo-controlled study with 251 patients with giant cell arteritis. A greater proportion of patients receiving subcuta...
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    European Regulatory Roundup: Parliament Seeks More Responsible Use of Antibiotics (10 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Parliament Endorses Plan to Encourage Responsible use of Antibiotics The European Parliament has endorsed a draft law intended to encourage the responsible use of antibiotics in animals. Under the terms of the proposal, the European Commission will monitor the use of animal antibiotics in member states and report the data regularly, while veterinarians will be made...
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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 ...