The Alliance for Safe Biologic Medicines (ASBM) today announced the results of a new survey on physician opinions relating to biologics and biosimilars. ASBM Chairman, Dr. Richard O. Dolinar, presented key findings during the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C., where he urged the FDA to make patient-safety the cornerstone of the biosimilars pathway.
The survey examined physician practices and perspectives with regard to biosimilar medicine identification and substitution – policy issues that remain unresolved and will have a fundamental impact on patient safety. Over 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists – all specialties that prescribe biologics – responded to the survey. Key findings from the physician survey demonstrate that patient safety must be a priority for all biosimilar policies.
- Inappropriate substitution is a major risk if different biologics have the same scientific name.
- 64% 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% view products with the same scientific name as structurally identical.
- Names are the primary means of product identification for physicians.
- The vast majority (99%) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events.
- Less than 1% 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% of responding physicians want the authority to designate a biologic medicine as “Dispensed as Written”, just as they have it for chemical products.
- 86% 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.
Dr. Dolinar, chairman of the Alliance, released the following statement about the conference and the survey results:
“In the past 30 years, biologic medicines have revolutionized the treatment of patients with many diseases – but making copies of these highly complex medicines presents significant challenges for physicians and regulators. This survey provides important information for effectively addressing these challenges. Biologics are produced from living cells and copies will be only similar, not identical to the original. This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients.
“We have been very supportive of the FDA’s efforts to create a pathway that ensures biosimilars are safe and effective for patients. This survey demonstrates the potential safety consequences of giving different biologic products the same scientific name. In order to avoid inappropriate substitution, all biologics should be required to have distinct names.”
Biologics are used to treat cancer, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.
Source: ASBM press release