THE US Food and Drug Administration (FDA) has finally released its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.
The guidance 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.
The FDA seeks input from interested persons on this topic.
Visit fda.gov for the draft.
The above article was sent to subscribers in Pharmacy Daily's issue from 19 Jan 17
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 19 Jan 17
