Tagged as: FDA Guidance

May 2019 FDA Guidance on Interchangeability Now Available

This month the FDA published its Guidance for Industry titled “Considerations in Demonstrating Interchangeability With a Reference Product”.  The guidance is “intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under…

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Comments and Letters to FDA in Response to Biosimilars Action Plan

The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…

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FDA Releases Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register.  The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results,…

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FDA Biosimilars Labeling Guidance

Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”).  The Biosimilars Labeling Guidance provides recommendations for biosimilar product labeling, specifically for the proposed package insert, and is intended to help applicants in drafting labels for an aBLA. Some highlights…

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FDA Releases Guidance for Industry Regarding Implementation of Biosimilar User Fee Amendments of 2017

The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”   This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to…

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FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars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