Industry Groups Call on FDA to Dispel Biosimilar Misinformation

Regulatory NewsRegulatory News | 28 February 2019 |  By 

The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars.

The AAM comment, related to Pfizer’s petition, specifically targets the term “non-medical switching” and the concept of interchangeability as areas where originator biologic companies and others have been misleading.

For instance, when a patient transitions to a biosimilar, some originator biologics stakeholder organizations have referred to the move as “non-medical switching,” which AAM calls “an ambiguous term” used “disingenuously to claim that transitioning from an originator to a biosimilar medicine is not safe, a claim that is not scientifically accurate. It also suggests that a decision is being made that is not justified by clinical evidence.”

FDA should clarify that the term “non-medical switching” in the context of provider-directed transitions to biosimilars is inappropriate, AAM senior vice president Christine Simmon writes.

In addition, Simmon says FDA should “clarify that only those patients who are stable on an originator biologic medicine are candidates for a transition to a corresponding biosimilar, contrary to misleading ‘fail-first’ policies seen in payer formularies that require patients to ‘fail’ on the reference product before they are able to access the biosimilar. In fact, if a patient ‘fails’ on a reference biologic, it would be clinically inappropriate to then have that patient move to the biosimilar, given the ‘highly similar’ nature of the two molecules.”

On the topic of interchangeability, AAM calls out Janssen for “disingenuously” overstating the role of the designation in the biosimilar marketplace.

“In using the interchangeability designation to cast doubt on the safety and efficacy of biosimilar medicines, Janssen specifically cites that ‘the fact that a biosimilar product may work the same way mechanistically as the reference product (e.g., same [Mode of Action] MOA) does not mean that the FDA has found that the products can be expected to produce the same clinical result.’”

But this statement “is false and ignores the BPCIA’s requirement that all biosimilars must have ‘no clinically meaningful differences’ from their respective reference product and have the same MOA,” Simmon writes.

Put simply, AAM says that the interchangeability designation reflects FDA’s conclusion that the statutory requirements for interchangeability have been met and “not that the biosimilar was altered or is of a higher quality.”

“Any misleading statements that conflate an interchangeability designation with higher quality, safety or efficacy must be countered by the FDA,” AAM adds.

And because the interchangeability designation is only intended to be pertinent in situations in which there is automatic retail pharmacy substitution, the association requests FDA emphasize, in its educational materials and on its website, that interchangeability is less common for biologics than small molecule drugs because the majority of biologics are physician-administered.

AAM also urges FDA to “clarify the nature of and consequences for disseminating misleading content related to biosimilars. In this regard, we request FDA bring about corrective actions by organizations who engage in misinformation campaigns.”

The PCMA similarly urges FDA to provide a framework whereby the veracity of claims with respect to biosimilars can be judged.

“Specifically, we echo the [Pfizer] 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,” PCMA said.



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