The U.S. Food and Drug Administration (FDA) has released a set of guidance documents for biosimilars. Together, the documents outline how the FDA will assess biologic drug exclusivity, biosimilars, and interchangeability. It is expected that the changes discussed will have a significant effect on data collection to support a biosimilar approval application.
According to the biosimilar guidance documents, the FDA will allow biosimilars to be formatted differently and/or delivered differently than the reference drug. However, any differences must be supported by data showing that there are no meaningful differences in quality, efficacy, potency, and safety. In general, analytical studies, a clinical pharmacokinetic study, and a pharmacodynamics study will be required.
The FDA has further announced that, by May 2017, electronic submissions will be required for new drug, generic drug, biosimilar, and biologic applications. Drug master files and new biologic product files — and any amendments to these files — must also be submitted electronically. Clinical trial applications must be submitted electronically starting in May 2018. The FDA is also planning to require electronic submission of drug promotional materials.
In addition, the FDA has released a draft guidance that formalizes the use of patient preference information in medical device approvals — a change that may make device approvals faster. Devices could potentially be approved for a subset of the relevant population. Another guidance recently released discusses planned medical device clinical trial changes that can be implemented over the course of a study. This change in practice could result in cheaper trials and a better chance of trial success.