AMCP Applauds First Biosimilar Approval, Cautions More Needs to Be Done

The approval of the US's first biosimilar is an important step in increasing access to life-saving and life-improving biologics, but it is just a first step.


Alexandria, Va., March 6, 2015 — “Today’s approval of the U.S.’s first biosimilar is an important step in increasing access to life-saving and life-improving biologics, but it is just a first step,” AMCP CEO Edith A. Rosato, RPh, IOM, said in response to the Food and Drug Administration’s action today. “Much work needs to be done to promote their use and acceptance.

“The FDA should next end the heated debate over biosimilars naming and require that biosimilars and their branded biologic counterparts share the same nonproprietary name. The FDA should also issue clear rules for designating a biosimilar product as interchangeable with a reference product.”

A recent survey of pharmacists published in the Journal of Managed Care & Specialty Pharmacy (March 2015) found ample evidence for the use of nonproprietary names to promote biosimilars’ use in the marketplace. Roughly three-quarters of pharmacists said they would feel confident or very confident substituting an interchangeable biosimilar for its branded biologic counterpart if the two products share the same nonproprietary name, according to the survey conducted by consulting firm Xcenda, an AmerisourceBergen company.

Conversely, only about 25 percent of pharmacists would feel as confident if the products had different nonproprietary names.

The findings also indicate that pharmacists, not to mention patients and prescribers, will require substantial education on biosimilars and interchangeable biosimilars prior to the launch of the first U.S. product. Education should focus on three areas: (1) instances where substitution is allowed according to FDA approval — i.e., as a biosimilar or interchangeable biologic, (2) appropriate recording of biologic dispensed for pharmacovigilance efforts, and (3) notification requirements driven by specific state laws.

About AMCP

The Academy of Managed Care Pharmacy is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit.