The FDA has finalized its long-awaited guidance on when biosimilars can be considered interchangeable with biologics.
Six things to know:
1. When a biosimilar gets an "interchangeable" designation, the therapy may be substituted for the biologic without the involvement of a prescriber, similar to how generics are substituted for brand-name drugs. Biologics can cost hundreds of thousands of dollars and biosimilars are expected to help lower these costs.
2. The final guidance aims to help promote competition in the biologic market and "provide clarity for developers who want to demonstrate that their proposed biological product meets the statutory interchangeability standard under the Public Health Service Act," according to the FDA.
3. While federal law created a pathway to drive more competition into the biologic market by introducing interchangeability, drug companies have been seeking greater guidance from the FDA about how to go about it.
4. In the final guidance, the FDA offered drugmakers some clarity on the studies they need to show their biosimilar is interchangeable with a biologic.
5. The final guidance helps clarify for drugmakers what data and information is needed to demonstrate interchangeability, how to design studies to show interchangeability and considerations for using so-called "switching studies" to determine whether alternating between a biosimilar and biologic affects the safety or efficacy.
6. The FDA has approved 19 biosimilar drugs, none of which are considered interchangeable.