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Home » FDA Seeks to Speed Insulin Biosimilar Approvals with New Guidance

FDA Seeks to Speed Insulin Biosimilar Approvals with New Guidance

November 25, 2019
Pharmaceuticals Submissions and Approvals
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance released on Monday.

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