On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe.
Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched from the reference product to the interchangeable.
ASBM submitted comments opposing the proposal and defending the current state law. From the comments:
As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.
States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients.
Read the full PDAB comments here.