Amgen Submits Comments to FDA on Biosimilars Naming Citizen Petitions
Amgen, a biotechnology company developing both innovative biologic and biosimilar medicines, today submitted its comments to the FDA on biosimilars naming citizen petitions from the Generic Pharmaceutical Association (GPhA) and Novartis.
Amgen is asking the FDA to consider some key points regarding the request by GPhA and Novartis for the same non-proprietary names for biosimilars of an originator biologic:
- Biosimilars licensed under the BPCIA are permitted design flexibility in their structure and composition, and are therefore not expected to be identical to the reference product or to each other
- Effective pharmacovigilance for all biological products will be facilitated by distinguishable non-proprietary names
- In the U.S., precise tracking is not possible if biosimilars share the same non-proprietary name as the original medicine
The FDA will weigh efficacy and safety in approving biosimilars, and Amgen fully supports the important role they are anticipated to play in bringing competition and potentially reducing health care costs. To support this, Amgen is asking for a regulatory environment for biosimilars that will foster effective monitoring of the safety profile of all biologics after they are approved.
Amgen is seeking distinguishable non-proprietary names, including the use of an identifier, for all of our biologic (innovator and biosimilar) medicines. Simply put, distinguishable non-proprietary names are an easily implemented and reliable means of advancing accurate product identification. We share this perspective with many in our industry.i