Tagged as: FDA

Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…

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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…

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Guidance on Biosimilar Submission Requirements in Canada

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”).  The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…

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FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization….

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UPDATED: FDA Requesting Comments on Biomarker List

FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December…

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