- Payers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
- July 22, 2014 | Authors: Laurie A. Clarke; Colleen Heisey; Mark Mansour; Christopher M. Mikson
- Law Firm: Jones Day - Washington Office
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic products—which are predicted to be as much as $100 billion over the first 10 years of biosimilar market formation.
In its letter to Commissioner Margaret Hamburg, the group argues that biologics and biosimilars should be required to have the same International Nonproprietary Name ("INN") in order to reduce provider and patient confusion and to promote swift uptake of biosimilar products when they come to market. Although no such products are currently sold in the United States, the group claims if biosimilars are marketed under unique names, then individuals might fail to recognize them as substitutes for brand-name biologics, which could stifle their use and hence undermine cost savings. The group also argues that using unique INNs would also disconnect biosimilars from existing safety information about their underlying molecules.
The Biologics Price Competition and Innovation Act of 2009 established a regulatory pathway for approving biosimilars, but FDA has yet to specify a naming policy for this category of products.