The FDA's updated guidance on the naming of biologics, biosimilars, and interchangeable products has caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
Earlier this month, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. The guidance holds that newly approved biologics, biosimilars, and interchangeable products will be assigned 4-letter suffixes, devoid of meaning, but it explains that the FDA no longer intends to require already approved products, including transition products, have such suffixes. The guidance caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
Sarfaraz K. Niazi, PhD, adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics, as well as the advisory company PharmSci, filed the petition on March 9, 2019. In the petition, he asks that the agency modify its position to state that no suffixes are required for any biologic products and instead state that brand names can be used along with National Drug Codes (NDCs).
In an interview with The Center for Biosimilars®, Niazi explained that “If you look at the labels [of biosimilars and their reference products] side by side, there is no possibility of any pharmacovigilance or traceability issue, and it has never been an issue.” He added that, for patients and prescribers, the presence of a suffix inappropriately suggests that there is a meaningful difference between the originator and the biosimilar. “In the minds of people, if you’re Mr. Johnson the third, you’re not Mr. Johnson the second,” he said.
When asked to respond to the FDA’s stated concern, expressed by FDA Commissioner Scott Gottleib, MD, that requiring already approved biologics to carry suffixes would be a costly undertaking, Niazi agreed that there would be substantial costs to innovator drug makers, from printing costs for labels to CMS coding considerations. However, he said, “there is no cost that is prohibitive to companies like Amgen.” According to Niazi, the FDA has long held that it makes its decisions on the basis of science, not cost to drug makers, a fact that makes concerns about these costs questionable.
Using suffixes for biosimilar products would be reasonable if suffixes served a purpose that could not be equally well served by using the brand names or NDCs for products, but the guidance served no purpose but to create a challenge for biosimilar acceptance and adoption, said Niazi.
Niazi’s citizen petition also asks that the FDA change its terminology used to describe biosimilars from having “no clinically meaningful differences” from the reference product to saying that products are “clinically similar.” Such a change, he said, would avoid confusion, and would keep reference product sponsors from capitalizing on potential ambiguity as a way to cast doubt on the safety and efficacy of biosimilars.
Finally, Niazi’s petition asks the FDA to warn biosimilar developers not to imply that their biosimilars are superior to other biosimilars, and to warn reference product sponsors against suggesting that the FDA is not competent to judge the safety and efficacy of these products.
The FDA has 180 days from the document’s March 14 acceptance to approve, deny, dismiss, or issue a tentative response to the petition.