Tagged as: Interchangeability

Vermont and Connecticut Enact Interchangeable Biosimilar Substitution Bills

Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills.  Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193.  The Act directs pharmacists to dispense…

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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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JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an interchangeability between biosimilars and their reference tumor necrosis factor-α (TNF-α) inhibitor counterparts. While this study only…

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