Timely survey released as FDA approves first biosimilar
The Alliance for Safe Biologic Medicines today released the results from a survey on physicians’ priorities related to biosimilar labeling. ASBM first shared the key survey findings at the “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. The survey reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.
A strong consensus was apparent among the four hundred physicians surveyed, all of whom are board-certified, practice in the U.S. and prescribe biologic medicines. They include dermatologists, endocrinologists, oncologists, nephrologists, neurologists and rheumatologists. ASBM Executive Director Michael Reilly presented at the autoimmune summit and discussed the role biotech medicines play in treating autoimmune diseases. His presentation addressed the recent approval of the first biosimilar medicine in the U.S. and the timeliness of the new survey data as FDA considers the multiple biosimilar applications said to be pending before the agency.
“ASBM commends the FDA for their work to make biosimilars a reality for patients across the country,” said Reilly. “We believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines. The survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.”
In the survey, participants were asked to rank the importance to the following questions on a five- point scale, with five being the highest:
- How important is it that a product label for a biosimilar clearly indicates that it is a biosimilar? 90% of respondents rate the importance as a 4 or 5.
- How important is it that the biosimilar label includes the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product? 82% rate the importance as a 4 or a 5.
- How important is it that the biosimilar label includes the clinical data, if any, submitted to FDA by the biosimilar sponsor to demonstrate that it is highly similar to the reference product? 83% rate the importance as a 4 or 5.
- How important is it that the label explicitly states that specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product? 79% rate the importance as a 4 or 5.
ASBM has conducted surveys on physicians’ understanding of and views about biologics and biosimilars in the U.S., in Europe and in Canada, with the goal of providing to regulators the information needed to help advance the success and safe use of biologic medicines around the world.
View the survey here.
View the one pager here.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.