Press Release
ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.
The bill would automatically declare all biosimilars as “interchangeable” with their reference biologics. Currently, manufacturers must demonstrate to the FDA that switching between their biosimilar and the reference biologic will not reduce safety or efficacy, jeopardizing patients’ treatment stability. If enacted, the bill would also overrule laws in all 50 states limiting pharmacy substitution to interchangeables. The state laws were widely supported by state medical societies and patient advocacy organizations, their support conditioned on the reassurances provided by the scientific standards the pending legislation would eliminate.
“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”
Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.
When informed of the proposal, physicians overwhelmingly oppose it. A recent survey of 270 U.S. biologic prescribers revealed:
- Only 11% support automatically classifying all biosimilars as interchangeable.
- 88% believe biosimilar switching studies increase their confidence in the safety of biosimilar substitutions.
- 69% agree that decisions about switching should remain between patients and their doctors, not insurers or pharmacies.
These findings underscore the widespread physician concern that the legislation undermines their ability to provide safe, personalized care. Indeed, 40 physician organizations recently sent a letter to Congress questioning the bill’s likelihood of increasing biosimilar access, and suggesting alternative ways to promote biosimilar uptake. The letter noted that “commercial plans including Medicare Advantage pay no attention to the interchangeability of a biosimilar when constructing formularies” [the list of covered medicines], they consider “only the size of rebates and fees collected.”
“Congress must prioritize patients over profits by retaining the rigorous standards that have earned physician trust and protected patients for nearly a decade,” said Reilly. “If policymakers truly want to promote biosimilar uptake, they should explore alternate pathways – ones that don’t erode safety standards, undermine physician confidence or risk destabilizing patient treatment plans.”
Media Contact:
Michael Reilly
media@safebiologics.org
(202) 222-8326
