FDA Unveils Draft Guidance on Biosimilar Interchangeability Data

Tuesday, February 17, 2015

Source: Smart Brief

The FDA has released draft guidance on the use of interchangeability data in biosimilar marketing applications submitted through the 351(k) pathway. According to the draft, applications should include data showing that a biosimilar is interchangeable and can generate the same clinical result as its reference biologic in all patients. The application or a supplement to the application should include the data demonstrating biosimilarity, the FDA suggests. Drugmakers can comment on the draft through April 6.

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