The Food and Drug Administration (FDA) issued draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”
The guidance is intended to provide recommendations to applicants seeking licensure under the Public Health Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all the reference product’s licensed condition of use. The guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product.
The FDA notes that this guidance is one in a series of guidances that the agency is developing to implement the Biologics Price Competition and Innovation Act of 2009. The guidance also notes that the FDA is committed to reviewing and acting on original 351 (k) BLAs and supplements within 10 months of the 60-day filing date.
The draft guidance provides recommendations on the following areas:
- Submission of an application seeking licensure of a proposed biosimilar or propose interchangeable biosimilar.
- Development of proposed labeling when the applicant seeks licensure.
- Submission of supplement to an application for a proposed biosimilar or proposed interchangeable biosimilar.
- Timing for submission of a 351 (k) BLA or supplement to a licensed 351 (k) BLA
Comments are due April 6.