Citizen Petition

Boehringer Ingelheim has filed a Citizen Petition asking the FDA to correct its interpretation of the term “strength” as used in the Biologics Price Competition and Innovation Act (“BPCIA”).

The FDA’s current interpretation of “strength” does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume, even if it has the exact same amount of active drug content as the reference product.

By working closely with industry peers, payors, healthcare providers, and patient advocates, and engaging in a transparent and public discussion of the issues we have raised, we believe that correction of the interpretation by the FDA may increase access to more affordable biosimilar and interchangeable biological products and benefit the healthcare system as a whole.

Please see below to read our full Citizen Petition to the FDA. We also encourage you to participate in this discussion and submit a comment to the FDA through the below link.