ASBM has released a new fact sheet explaining the risks posed by the Biosimilar Red Tape Elimination Act (BRTEA, S. 1954).
Today, FDA evaluates each biosimilar individually before determining whether it is interchangeable—meaning it may be substituted at the pharmacy without the prescribing physician’s approval. BRTEA would eliminate that product-by-product scientific review and automatically deem every biosimilar interchangeable upon approval, including products for which FDA has not determined that switching presents no additional risk.
This would newly empower insurers and pharmacy benefit managers to switch stable patients for non-medical reasons—such as cost or profitability—rather than patient need. It would also make the United States an outlier among advanced nations, where pharmacy-level biosimilar substitution without physician involvement remains uncommon or is prohibited.
Physicians overwhelmingly oppose this approach. In a recent survey, 88% of U.S. physicians said FDA should continue evaluating switching safety product by product, while only 11% supported treating all biosimilars like generics.
BRTEA does not simply eliminate “red tape.” It removes FDA scientists, physicians, and patients from an important treatment decision and transfers that authority to insurers and PBMs.
