Tagged as: FDA Guidance

FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic.  Today, FDA withdrew this draft guidance….

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FDA Announces New Draft Guidance on Meetings Regarding the Development and Review of Biosimilar or Interchangeable Products

On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products.  The draft guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products,” is available here.  FDA also…

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FDA Releases Two Draft Guidances on REMS

For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks.  For an overview on REMS click here.  We have previously reported that FDA received numerous inquiries from generic…

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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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FDA Offers Perspectives on Enhancements to the Application Review Model

In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…

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FDA Plans to Release Biosimilarity Guidances in 2016

Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…

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