AGA Makes Six Recommendations to FDA on Interchangeable Biosimilars

Source: American Gastroenterological Association, May 25 2017

Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. Last week, AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments … [view full article]