Tags : Interchangeability

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Shots: The FDA has released draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the […]Read More

The US FDA to Waive Interchangeability Standard for Insulin Biosimilars

Shots: Two doctors called for interchangeability requirements for biologics to be waived for insulin products under the Biologics Price Competition and Innovation Act (BPCIA) of 2009 The FDA guidance is a reminder that the rules of BPCIA should be carefully reinterpreted in order to maximize benefit, affordability, and access to insulin for all patients with […]Read More