The US FDA will make its draft requirements for demonstrating the interchangeability of biosimilars and their reference biologic less burdensome to help stimulate development of follow-on products, Commissioner Scott Gottlieb said at an April 19 policy conference sponsored by the Pharmaceutical Care Management Association.
The agency is working on a "suite of policies aimed at making incremental gains in trying to facilitate market entry of biosimilars" and "in that suite of policies we'll be updating the guidance on interchangeability and trying to see about how we can create a lower hurdle for companies demonstrating interchangeability