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