2017-05-25 14:32:44 UTC

AGA Makes Six Recommendations to FDA on Interchangeable Biosimilars

May 25, 2017

AGA provides guidance to FDA to ensure patient safety and empower physicians.

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 Last week, AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about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 (read the full letter).

1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.

Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise. 

2. The agency should use caution when allowing extrapolation for pediatric indications.

Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.

3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.

Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.

4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.

A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products. 

5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.

AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication. 

6. Prescribing physicians must be empowered with the ability to prevent non-medical switching from a reference product to an interchangeable product.

AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health-care providers must be empowered to be aware of and prevent non-medical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars. 

AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.

For more information on the advent of biosimilar products in the U.S. watch the DDW TV interview with Dr. Gary Lichtenstein.


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