For Immediate Release:
October 13, 2015
WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling.
“This survey reinforces what ASBM has been hearing from pharmacists through our Continuing Education programs and makes it clear that they prefer distinguishable names and more complete specific approval labeling for biologics than is currently called for by the FDA,” said Executive Director Michael Reilly.
When asked if the FDA should require distinct non-proprietary names for all biologics, including biosimilars, 68% of pharmacists replied “Yes”, 23% said “no”, and 8% had no opinion.
“These results are not surprising;” said Ronald P Jordan, Dean at Chapman University School of Pharmacy, Orange County, CA and former President of the American Pharmacists Association (APhA). “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”
Regarding the labeling of biosimilars, the ASBM survey reveals that pharmacists want greater transparency than the FDA currently requires. When asked to rate from 1-5 the importance of certain information being included on a biosimilar’s label, high percentages rated the following as a “4” or a “5”, indicating high importance for inclusion:
- 81%: Identifying the product as a biosimilar
- 88%: Whether or not the biosimilar is interchangeable with (safely substitutable for) its reference product
- 76% In which approved indications the biosimilar was studied, and for which approval was based on extrapolation from studies in other indications
- 69% Distinguishing the source of data provided (originator product or biosimilar)
None of this information is currently present on the label of the only approved U.S. biosimilar, Zarxio (filgrastim-sndz).
“Pharmacists depend on the product label to advise patients and others on safe use, said Jordan. We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance.” Dean Jordan, who has served as a member of the ASBM Advisory Board since 2012, presented some of the data at the WHO’s 61st Consultation on International Nonproprietary Names (INN) today in Geneva.
The full pharmacist survey may be viewed 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.
For more information, please contact:
Alliance for Safe Biologic Medicines