Some tidbits from Salvatore J. Giorgianni, Jr.’s docket submission to the FTC hearing on biosimilar naming, (Giorgianni, PharmD, BSc, CMHE, is Chair of the American Public Health Association Caucus On Men’s Health and President, Consultant Pharmacist, Griffon Consulting Group, Inc.)
Patients across the US and in every other country in the world will be best served if distinguishable names are required for all biologics and their biosimilar follow on compounds. Providing clarity of information with distinguishable names or codes that are transparently traceable back to the point of bio-manufacture and ending at the point of dispensing/administration to the consumer is essential to keeping a secure process that insures patient safety. As history shows, the integrity of drug and biologic supply and the ability to properly manage clinical care require clear unique product identification. Such unique naming/coding also continues FTC’s long and valued tradition of advocating for full and transparent disclosure of product information for the consumer
The importance of providing for specific and precise product identification is of heightened importance with biosimilar products and their presumed biotherapeutic equivalents because of the large proportion of immunocompromised, frail and vulnerable populations with complex and life-threatening medical conditions that are most likely to receive these products.
In the truest sense of the word, the assertion of biotherapeutic equivalency by some in support of non-unique product designations is by any convention a scientific hypothesis that needs to be validated.
As a practicing pharmacist and compounding pharmacist for 30 years and former pharmacy educator I feel strongly that the ability to precisely know and rapidly trace back product components and identity is fundamental to protecting the health of patients. Having distinguishable product identification for biosimilar products, in my view, seeks to provide the most direct route back to the root of an issue if an adverse event occurs and being able to do this is part of the standard of practice for all pharmacists.
Salvatore J. Giorgianni, Jr., PharmD, BSc, CMHE
Chair, American Public Health Association Caucus On Men’s Health
and President, Consultant Pharmacist, Griffon Consulting Group, Inc.
Giorgiann’s complete docket submission can be found here.