On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability.

DIA Presentation on Biosimilar Naming
DIA Presentation on Interchangeability

During the conference, ASBM released a new survey examining physician practices and perspectives with regard to biosimilars and substitution.

Results showed:

Inappropriate substitution is a major risk if different biologics have the same scientific name.

  • 64 percent of surveyed physicians assume if products have the same name a patient can be safely switched from one product to another during treatment.
  • More than 76 percent view products with the same scientific name as structurally identical.

Names are the primary means of product identification for physicians.

  • The vast majority (99 percent) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events.
  • Less than 1 percent of prescribers use national drug code numbers for records or reporting.

Physicians are very concerned about a patient being switched from one biologic to another.

  • 85 percent of responding physicians want the authority to designate a biologic medicine as “Dispensed as Written”, just as they have it for chemical products.
  • 86 percent of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.

View the ASBM Biosimilars Survey.