On October 27th, 2015, ASBM submitted comments on the FDA’s “Guidance for Industry Nonproprietary Naming of Biological Products”, released August 28th. The Draft Guidance called for distinguishable names for all biologic medicines, including biosimilars. This would be accomplished by use of a four-letter differentiating suffix composed of random letters.
In the comments, ASBM commended the FDA for its leadership on biologic naming and praised the FDA’s Draft Guidance, calling it ” a significant positive step” in advancing the goals of improved patient safety, pharmacovigilance, and understanding of biosimilars in the U.S. and globally.
“Physicians and pharmacists know that their ability to improve patient outcomes and safety is hampered unless they can clearly distinguish similar biologic medicines from one another”, the comments read in part.
Both the need for distinguishable naming and support for it among health providers has been documented by ASBM’s surveys of health providers in eleven countries. This included two recent surveys of 400 U.S. prescribers of biologics and 401 U.S. pharmacists.
The soon-to-be released U.S. prescriber survey, conducted in October 2015, revealed that two-thirds of physicians (66%) support the FDA issuing distinct nonproprietary names to all biologics, including biosimilars. Only 11 percent oppose this, while 23% had no opinion. A 2014 survey of 427 Canadian physicians had previously found that 79% supported the use of distinguishable names.
Additionally, 94% percent of the 399 biologic prescribers surveyed in Latin America this year supported the WHO’s BQ proposal (which like the FDA’s proposal would use a four-letter differentiating suffix) as a “useful” tool to help ensure that their patients receive the proper medicine.
This need and desire for clarity is not limited to physicians. ASBM’s October 2015 survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.
While in favor of differentiating suffixes, ASBM supports upon the name of the product’s manufacturer, as was the case with the FDA’s first biosimilar approval, Zarxio (filgrastim-sndz), rather than suffixes composed of random letters. Manufacturer-derived suffixes were supported by majorities of health providers surveyed (60% of physicians and 77% of pharmacists) because they are easier to remember and promote manufacturer accountability for their products.
The comments may be read in their entirety here.
The comments were signed by ASBM’s Chairman Harry Gewanter, its Advisory Board Chair Philip Schneider, its Steering Committee, and endorsed by 47 additional stakeholder groups.