The FDA is in the process of developing a pathway for interchangeable products where biosimilars can be "substituted for the reference product without the intervention of the health care provider who prescribed the reference product," according to an American Gastroenterological Association release.
The AGA made six suggestions to the FDA focused on enhancing patient safety and ensuring physicians were the deciding factor behind the decision, not payers.
Here's what you should know.
1. The FDA should not allow data extrapolation if pathophysiology is different or yet to be explained — The AGA wants manufacturers to seek licensure for all similar indications as the reference product to track all associated adverse events.
2. The FDA should cautiously allow extrapolation for pediatrics — The AGA recommends the FDA make an exemption for pediatric patients until data ensures the practice is safe for children.
3. The FDA should limit sponsors to U.S.-licensed reference products in switching studies — The AGA wants the FDA to modify or remove the clause entertaining the use of non-U.S. products.
4. Associated parties should collect data through post-marketing observational studies to ensure safety for all patients.
5. The FDA should consult gastroenterologists with expertise in the subject.
6. Prescribing physicians should be allowed to prevent non-medical switching from the reference product to an interchangeable product, when applicable — The AGA wants the FDA to protect physician discretion.
To read the full text of the recommendations, click here.