FDA Extends Comment Period on Biosimilar Interchangeability Guidance

March 17, 2017

The FDA has extended the comment period for its draft guidance on developing interchangeable biosimilars to May 19, after receiving requests for an extension.

PhRMA and BIO asked for the extension to review the scientific and regulatory recommendations in the draft guidance.

The draft guidance, which was published in January, recommends sponsors use switching studies to demonstrate biosimilar interchangeability.

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