The FDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by August 31, 2015.
The FDA estimated it expects to receive five biosimilar product applications and two interchangeable product applications or supplements per year. The agency also said it plans to issue a draft guidance this year addressing biosimilar interchangeability entitled “Considerations in Demonstrating Interchangeability to a Reference Product.”