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Determining standards for biosimilar insulin
February 2020
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The FDA released a draft guidance on biosimilar insulin products in late 2019 titled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The guidance details what data may or may not be required to support an argument of biosimilarity or interchangeability for an insulin product, and notes that strict standards will need to be met. In addition, beginning March 23, approved New Drug Applications for biological products will be considered licenses for the products (i.e. approved Biologics License Applications) under section 351 of the Public Health Service Act, according to a statement from FDA Commissioner of Food and Drugs Dr. Brett P. Giroir. Once an approved NDA is deemed to be an approved BLA, the product, such as an insulin alternative, can be used as a “reference product” against which a biosimilar or interchangeable product can be compared. The FDA began accepting comments on the draft guidance on Nov. 29.

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