DC District Court Provides Guidance as to the Meaning of 'Protein' Under the BPCIA | Kramer Levin Naftalis & Frankel LLP
In December 2020, the U.S. District Court for the District of Columbia issued a Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone ®, a medication for treating multiple sclerosis, is a “drug” rather than a “biological product.” Biologic products are regulated under the Biologics Price Competition and Innovation Act ( BPCIA), which has more arduous requirements for approval of follow-on biosimilar or interchangeable products than those for generic drugs. Following several failed efforts to have FDA reclass...
Source: jdsupra.com