By Michael Reilly,
Executive Director, ASBM
To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz).
The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable names over random because they are easier to recognize and remember.
Yet there’s another reason for the FDA to stick with the original meaningful/manufacturer-based naming system over random: it’s a far better means of promoting manufacturer accountability.
Think of red-light cameras. You probably don’t run many red lights, but do the cameras make you more likely to stop for a red light, knowing that your infraction will be certainly and immediately traced to you? Sure they do. Likewise, manufacturer-based names for biosimilars will incentivize the manufacturer to make a product they can stand by, since a problem with the medicine will certainly and immediately reflect poorly on the company’s name and reputation.
As a former regulator at HHS, part of my job was holding insurers accountable for the decisions they made regarding Medicare beneficiaries. For example, I helped create a system by which patients who were denied Medicare-approved treatments by a private insurer could appeal those decisions. Providers who were found to be abusing the system faced swift consequences- up to and including being banned from further Medicare contracts. We designed a system where the increased likelihood of negative consequences promotes good health outcomes for patients and good behavior among contractors.
Put simply, compliance with regulations is higher when there is a more credible chance of negative consequences – whether it be a traffic ticket, or a reputation as a manufacturer that provides substandard products or services to their patients.
Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. He served in the Secretary’s Office at the U.S. Department of Health and Human Services (HHS) from 2002-2008, including three years as Associate Deputy Secretary.