The U.S. Federal Trade Commission (FTC) has scheduled a December 10, 2013, public workshop in Washington, D.C., "to explore competition issues involving biologic medicines and follow-on biologics. The workshop will focus on the potential impact of state regulations and naming conventions on such competition, including how regulations may be structured to facilitate competition while still protecting patient health and safety." The workshop will be Webcast, and comments are requested by March 1, 2014.
FTC notes that some states have adopted laws regulating "the substitution of biosimilars or interchangeable biologic products for reference biologic products." How these initiatives may affect competition is among the matters that will be addressed during the workshop. It will also explore the effects of allowing biosimilars to have the same nonproprietary names as reference products, as well as approaches taken in other countries to biosimilars. See Federal Register, November 15, 2013.
In a related development, six bipartisan senators and congressional representatives have addressed the issue of biosimilar naming in a November 13 letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg. They assert that it was Congress’s intent, when enacting the Biologics Price Competition and Innovation Act, "to provide the FDA with the flexibility to establish a science-based policy for non-proprietary naming of drug substances, and not to encourage the FDA to adopt a policy of either identical or differentiated naming. It is not the role of Congress to predetermine decisions that should be based on scientific evidence."