The Food and Drug Administration (FDA) is currently under scrutiny from the United States Senate due to the FDA’s inability to release certain guidance documents on biosimilars in a timely fashion. Speaking in front of the Senate Subcommitee on Primary Health and Retirement Security on September 17, 2015, Janet Woodcock, the director of the Center for Drug Evaluation and Research, explained that the delay in releasing the much anticipated guidance documents, which namely focus on the interchangeability and labeling of biosimilars, is a result of the scientific complexity of biologics and biosimilars and the complicated authorization process.
Biologics, such as Humira and Enbrel, comprise many of today’s most important medications, and are derived from a variety of living organisms and microorganisms, including humans, animals, bacteria, and yeast. As such, biologics are much more complex in structure than conventional drugs and do not allow exact replicas to be produced. “Biosimilars,” therefore, are biological products that are highly similar to an already approved FDA biologic and have no clinically meaningful differences in terms of safety, purity, and potency. Biosimilars were created under the Biologicals Price Competition and Innovation Act of 2009.
In April 2015, FDA finalized three guidance documents related to biosimilars. However, Woodcock was unable to provide any specific dates to the Senate Subcomittee as to the release of guidance documents pertaining to interchangeability and labeling. Woodcock did assure, however, that additional guidance documents on biosimilars would be released during the calendar year.
Federal and state regulations of biosimilars are becoming increasingly more complex. Contact Frier Levitt for assistance in ensuring that your practice or pharmacy is in compliance.
