by Amanda Conschafter, blog editor
Much more than simply a sticker on a medicine bottle, drug labels – or “prescribing information”—provide physicians with crucial information about medical therapies. But a new video from the Alliance for Patient Access suggests that the FDA-approved prescribing information for the first U.S. biosimilar falls short—and could set a concerning precedent for future biosimilars.
As “What Physicians Need to Know to Safely Prescribe Biosimilars” notes, physicians look to prescribing information for a drug’s dosing levels, approved uses and potential safety concerns. Yet the first U.S. biosimilar carries the same prescribing information as its reference biologic, even though the two are not identical—and “may not have identical results for patients.”
The FDA’s decision presents potential problems, as even minor differences between biologics and biosimilars can trigger adverse responses. And as a precedent for future biosimilars, it would fail to provide the transparent, comprehensive data physicians need, the video notes.
For physicians to have full confidence in prescribing biosimilar medications, the video explains, they need certain basic details:
- Whether the medication is a biosimilar
- Data from tests or clinical trials conducted with the biosimilar
- Clear information on whether data provided is from clinical trials of the biosimilar or of the original biologic
- Which medical conditions were tested with the biosimilar.
Prescribing information that includes these details allows physicians to determine which biological medications are safe and suitable for their patients.
To learn more, watch “What Physicians Need to Know to Safely Prescribe Biosimilars.”