Stakeholders Urge FDA to Finalize Biosimilar Guidance

A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its January 2017 draft guidance created “significant uncertainty.”

The FDA issued the draft seven years after Congress passed the Biologics Price Competition and Innovation Act that introduced an abbreviated licensing pathway for biologics demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. “Interchangeable” means the biologic is expected to produce the same result for any given patient as the original medicine and pharmacists could substitute without asking the doctor or patient.

The agency’s delay in issuing final guidance has created a lack of clarity, according to the Aug. 23 letter from 17 organizations (including Blue Cross Blue Shield, Kaiser Permanente and CVS Health) to FDA Commissioner Scott Gottlieb. The FDA has approved 12 biosimilars but none have been ruled interchangeable.