FDA Takes Steps to Streamline Biosimilar Development
The FDA announced a new draft guidance that would streamline unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. This draft guidance provides updated recommendations to prospective biosimilar applicants seeking to use data from a comparator product approved outside the U.S. as evidence that a proposed product is biosimilar to the U.S.-licensed product. The recommendations describe scenarios in which a biosimilar applicant may use clinical data from outside the U.S. without additional data from a three-way PK study.
FDA Moves to Accelerate Biosimilar Development
The FDA announced plans to expedite the development of biosimilar medications to introduce more, lower cost drugs to the market and help treat serious and chronic disease. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce clinical testing. The FDA's new guidance reduces the requirements for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences. The FDA also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. According to the FDA, biologic medications make up 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024.
