17 January 2017 - The US FDA has finally released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

The guidance, which was initially expected to be published before the end of 2015, recommends that sponsors looking to get a biosimilar approved as interchangeable with its reference product conduct one or more switching studies to show that patients can alternate between the two products safely and without diminished efficacy.

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