Teva Pharmaceuticals filed suit against the United States Food and Drug Administration (FDA) alleging that its glatiramer (Copaxone) falls under the revised definition of a “biological product” and should be transitioned to the system established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). If Teva is ultimately successful, generic competitors would be forced to meet the higher standard for biosimilar approval and interchangeability for Teva’s drug. This could also open the door to other companies seeking a transition of their products to the biologics framework. Teva’s lawsuit was filed in the midst of the ongoing COVID-19 pandemic, which has prompted many courts to delay cases for months, and a decision in this case will likely be similarly delayed.
The BPCIA provides an abbreviated pathway for the approval of generic products that show “no clinically meaningful difference” to reference “biological products.” Recognizing that some of these biological products were previously approved under the New Drug Application (NDA) process, Congress gave the FDA ten years to convert those products from the NDA framework to the BPCIA framework. To prepare for this transition, the FDA invited comments from the industry regarding the definition of a “biological product.”
After a period of review and comment, the FDA defined “biological product” under the BPCIA to include all proteins with “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.” The FDA also published a preliminary list of drugs that would be converted to the BPCIA on March 23. Teva filed a comment to this preliminary list and asked that its copaxone product, a synthetic polypeptide, be added to the list. The FDA did not provide a response to Teva’s comment, and finalized the list of drugs to be converted to the BPCIA without copaxone on the list. Teva filed suit the day after the transition, arguing that the BPICA mandated the FDA convert all drugs that qualified as a biological product to the BPCIA framework.
Teva’s arguments primarily rest on a statutory interpretation of the BPCIA, which provides that a previously approved NDA for a biological product “shall be deemed a license for a biological product under [the BPCIA].” The purpose for the transition, however, likely cuts against Teva’s case. The FDA stated that the transition of certain drugs was needed to facilitate generic versions of drugs that were historically difficult to develop. However, companies had already developed and been approved for generic versions of copaxone as Abbreviated New Drug Applications.
If Teva is successful, copaxone competition may decrease because future generics would now have to meet the higher standard in the BPCIA that requires a showing of “no clinically meaningful difference” to the reference biological product. To date, the FDA has approved only 26 biosimilars under that standard, and no biosimilar has met the even higher standard for interchangeability. Thus, until the FDA provides practical options to navigate the BPCIA more effectively, competition for copaxone may be stifled. Finally, a victory by Teva may open the door for requests for the transition of other drugs (that already have generic competition) to the BPCIA, leading to decreased generic competition for those drugs.