The Novartis and GPhA Citizen Petitions request that the US FDA require biosimilars licensed under the Biologics Price Competition and Innovation Act to bear the same international nonproprietary names (INNs) as their reference products.
But AbbVie, Genentech and Amgen are calling for that petition to be rejected so that adverse events in post-market safety studies can be directly tied to the specific products.
As far as the reasoning behind this group’s call to reject this petition, Genentech notes that because “immunogenic events are often rare, premarket testing may not identify them, increasing the need for accurate postmarket surveillance…It is therefore important to attribute new or changed adverse events to the correct biologic without implicating an entire product class.”
Abbvie urges in its comment that the agency not require biosimilars to have the same INNs as their reference products, and instead to follow Janssen’s previous call to “require biosimilars to have nonproprietary names that are distinguishable from, yet related to, the names of their reference products.”
The company also says that the GPhA and Novartis petition fails “to take into account fundamental scientific principles of biological products as well as their distinctive posology and methods of administration in clinical practice.”
Industry group BIO also previously denounced the GPhA and Novartis petition, noting similar names could cause confusion for patients and doctors.
Amgen further argues in its comment that the petitioners’ proposal “would raise the types of patient safety, provider confusion, and pharmacovigilance issues to those that facilitated FDA in the past to require distinguishable names for non-identical biological products.”
Genentech seems to agree, noting in its comments on the petition, that not only are the structures of biologics “much more complex” than small molecule drugs, but biologics “are heterogeneous due to their manufacture in living cells and the complexity of their manufacturing processes.”
The availability of a number of related biologics, including some that are deemed interchangeable, will only add to the complexity of postmarketing safety monitoring and prescribing.
“The approval of the first biosimilars will make accurate attribution even more important and more complicated,” Genentech says, noting the importance of effective post-market safety monitoring. “Distinct nonproprietary names will enable attribution of adverse events to the correct product, whereas other product-identifying information is not reliably available in adverse event reports.”
The argument comes as industry giants show similar divisions. A recent hearing at the US FTC (Federal Trade Commission) did little to clarify how biosimilars should be named moving forward, though companies seem eager for the FDA to begin approving biosimilars.
Hospira also previously weighed in and took the side of Novartis, saying INNs should be the same for biologics and biosimilars.