Patients must have access to safe and effective biologic and biosimilar medicines.
- Ensure that FDA approval of biologics and biosimilars are based on the same standards of safety and efficacy of other FDA approved products. In order to assure that patients realize the promise of biosimilars, FDA should finalize its standards for their oversight and approval to prove biosimilars are as safe and effective as the reference innovative biologics;
- Because of variations in the complexity of biologics, FDA standards for the review and approval of biosimilars should not provide for a “one-size-fits-all” approach that could impact product efficacy or threaten patient safety;
- FDA should enforce the provisions of Biologics Price Competition and Innovation Act (BPCIA) that a biosimilar is “highly similar” to the reference biologic and that “there are no clinically meaningful differences” between it and the reference product “in terms of the safety, purity, and potency of the product;”
- FDA should require high standards, including data and clinical trials in determining whether a biosimilar is “interchangeable” and can be expected to produce the same clinical result as the reference product in any given patient.
Prescribers and patients should have all the information necessary to make a fully informed choice about whether to use an innovative biologic or biosimilar.
- There should be no automatic substitution of biosimilars for biologics. The choice of products should not be determined by a pharmacist, regulator, or insurer but by a prescriber in consultation with his or her patient;
- If automatic substitution is adopted either through regulatory or legal standards or implemented independent of a regulatory or legal authority by an insurer, the patient and their prescribing provider must be notified immediately before a switch between an innovative biologic and biosimilar occurs;
- There must be adequate information about biosimilars available to prescribers and patients in a format that is appropriate for each audience and allows them to make an informed choice.
Steps must be taken to assure appropriate tracking of adverse events for all biologics, including biosimilars, so that safety problems are promptly and accurately identified.
Biosimilars should have unique nonproprietary names to eliminate confusion, allow prescribers to accurately track the therapeutic agent in a patient’s medical record and quickly trace a product to an adverse event.
Biosimilar pathways should support innovation and ensure incentives remain to bring new therapies to market for patients.