Updated: Pfizer Calls for Compromise on Retroactively Using Suffixes in Biologic Names
Posted 08 May 2019 | By
In response to the US Food and Drug Administration’s (FDA) proposal to not go back and rename certain biologics with nonsense suffixes, as it once said it would, Pfizer is calling on the agency to at least retroactively apply suffixes to biologics that serve as reference products for biosimilars.
Such a compromise would reform the initial proposal and ensure the nonproprietary names of biosimilars, with their four-letter nonsense suffixes, would at least look similar to the nonproprietary names of their reference products.
“Further, the Agency should be flexible regarding the amount/length of time innovator biologics manufacturers/companies would have to retroactively implement the convention in order to ensure such manufacturers/companies can develop processes and implement the new convention efficiently;
and, without disrupting supply or impacting pharmacovigilance,” Pfizer said.
FDA has said the decision to use the suffixes, which no other country in the world does, is part of the agency’s focus on pharmacovigilance, but Pfizer made clear that the suffixes are not currently being used as intended.
“In order for the proposed naming convention to prevent this kind of inaccurate reporting for biological products the suffix would have to be consistently utilized in pharmacovigilance reporting. Based on experience to date, the suffix is rarely included in adverse event reports,” the company said.
Even FDA’s biosimilars acting director said last week at the Food, Drug and Law Institute’s annual conference that she was “not a great fan” of the updated naming guidance.
The Federal Trade Commission (FTC), meanwhile, said the updated guidance "would likely create unnecessary barriers to entry for lower cost biologic products that are biosimilar to or interchangeable with existing FDA-approved biologic products."
FTC recommends FDA "abandon the use of these suffixbased naming proposals."
The Association of Accessible Medicines also called on FDA to completely do away with its proposal. "Failure to do so puts the potential of the U.S. biosimilars market at risk of failing to fulfill their promise of access to affordable biosimilar products to America’s patients and the relief they have provided globally," the group said.
Similarly, Susan Cantrell, CEO of the Academy of Managed Care Pharmacy, told Focus in a statement: “FDA’s updated draft guidance on biosimilars naming undermines their efforts to promote the use of biosimilars. Creating two separate naming conventions for the same class of products will confuse providers and reduce uptake, potentially leaving billions of dollars in savings on the table at a time when our nation desperately needs to lower health care costs.”
On the other side of the fence, industry group BIO pledged its support for the updated naming convention “to facilitate effective pharmacovigilance practices.”
But BIO also called for vaccines to not have to adopt such suffixes, as the group said it believes that “FDA’s evaluation of vaccine identification systems will establish that they are sufficiently robust to ensure safe dispensing practices and optimal pharmacovigilance.”
Updated on 5/8/19 with information on the FTC's and AAM's comments on the FDA guidance.