On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247. Boehringer Ingelheim seeks an interpretation of “strength” to
