The Association for Accessible Medicines (AAM) Biosimilars Council, along with the Pharmaceutical Care Management Association (PCMA), are supporting a Pfizer petition to the US Food and Drug Administration (FDA) to increase efforts in counteracting “untruthful or misleading” information on biosimilars.
The term “non-medical switching” and the concept of interchangeability are points of contention for AAM and PCMA, citing their belief that originator biologic companies and others have been misleading in these areas.
AAM believes that the term “non-medical switching,” used to describe a situation where a patient transitions to a biosimilar, is “ambiguous” and is used “disingenuously to claim that transitioning from an originator to a biosimilar medicine is not safe, a claim that is not scientifically accurate.” In turn, the FDA should clarify that “non-medical switching” in the context of provider-directed transitions to biosimilars is inappropriate, according to Christine Simmon, senior vice president, AAM (February 28, 2019).
The Biosimilar Council also implored the FDA to clarify that only patients who are stable on an originator biologic medicine should be eligible to transition to a biosimilar, contrary to “fail-first” policies in payer formularies.
On the topic of interchangeability, the Biosimilar Council stated that such designation reflects the FDA’s stance that the statutory requirements for interchangeability have been met and “not that the biosimilar was altered or is of a higher quality.” They added, “Any misleading statements that conflate an interchangeability designation with higher quality, safety, or efficacy must be countered by the FDA.”
Similarly, PCMA has urged the FDA to offer a framework designed to consider claims made with respect to biosimilars. “Specifically, we echo the petition’s call for the FDA to issue guidance that discusses the types of sponsor communications about reference products and biosimilars that would be inappropriate because they would be false or misleading,” a representative from PCMA stated (February 28, 2019).—Zachary Bessette