On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA demonstrating that the safety and efficacy aren’t diminished even after repeated switching with the original biologic. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars. From the comments:
ASBM respectfully disagrees that the interchangeability statement is not valued by prescribing health care professionals. In a survey of 400 US physicians who prescribe biologics, participants were asked how important it is that the product label clearly indicates that a biosimilar is or is not interchangeable; approximately 80% of physicians rated the importance of this either a 4 or 5 on a 5-point scale. Likewise, a survey of over 400 pharmacists indicated that almost 90% of those polled rated the importance of the product label clearly indicating that a biosimilar is or is not interchangeable as a 4 or 5 on a 5-point scale. ASBM believes FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy- level substitution of that biosimilar in place of the prescribed originator. Only a third of physicians surveyed indicated that an interchangeable designation would not affect their prescribing behaviors.