Biosimilar Switching Studies, Human Factors Analyses Are Flashpoints For Industry
US FDA should offer more flexibility on endpoint in clinical switching studies for interchangeability, generic companies say in comments that also argue a draft guidance recommendation for human factors studies to compare use error rates between products is misplaced.
You may also be interested in...
US FDA guidance lays out two types of study design recommendations: a dedicated study to demonstrate interchangeability, and an integrated study intended to support determinations of both biosimilarity and interchangeability.
US FDA seeks stakeholder views on manufacturing changes, new reference product indications and other questions that build on its draft guidance for approval of interchangeable biosimilars.
Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.