Tagged as: Clinical Trial

Biosimilar Clinical Trial Updates

Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials.  A summary of these developments is below. Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept).  According to Clover, the trial is designed to…

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Glenmark Reports Positive Phase 1 Results on Biosimilarity of GBR 310 to Omalizumab

Glenmark Pharmaceuticals announced positive results in a Phase 1 study comparing biosimilar GBR 310 to omalizumab, marketed as Xolair® by Genentech and Novartis.  According to Glenmark, the study supports similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles. Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate…

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Paper reports on administration of adalimumab biosimilar using an autoinjector

Earlier this month, the journal of Expert Opinion on Drug Delivery published results from a clinical study of BI 695501, an adalimumab biosimilar, using an autoinjector (AI).  BI 695501 is a self-injectable adalimumab biosimilar that according to the publication has “demonstrated PK bioequivalence and similar clinical efficacy, safety, and immunogenicity with…

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