Novartis has urged the US Food and Drug Administration to ignore calls for it to impose unique international non-proprietary names on biosimilars, as doing so would “undermine the safe use of all biologics by introducing unfounded confusion into the healthcare system.”
The firm has petitioned the FDA to maintain its requirement that biologics be identified by the same INN as the reference product, “to encourage and protect the safe and rational use of all medicines.”
While the Biologics Price Competition and Innovation Act (BPCIA) of 2010, which established an FDA approval pathway for biosimilars, is “appropriately silent” on this issue, there has been considerable public debate, which has included the implication that the INN’s purpose is to facilitate identification of a specific product, says Novartis.
“This implication is untrue and has resulted in confusing an otherwise straightforward issue,” it says.
The Alliance for Safe Biologic Medicines (ASBM) - whose members include patient advocacy groups as well as manufacturers Amgen and Genentech - is calling for all biologics to be given distinct INNs, to “enable regulators to hold manufacturers accountable for the quality of their medicines.”
Addressing the World Health Organisation (WHO) on this issue in Geneva last month, Alliance chairman Richard Dolinar said: “if a patient has an adverse reaction, which can occur months after receiving a biologic medicine, we need to be able to properly identify that medication. Instituting a system of distinguishable names will achieve the common goal of enhancing access to these life-changing therapies, while also protecting the safety of the patients.”
However, the US Generic Pharmaceutical Association (GPhA) and the European Generics Association (EGA) urged WHO to maintain the established INN naming system. Adding further layers of requirements would likely create confusion, slow adoption of biosimilars and potentially give rise to medical errors, GPhA warned.
In its petition to FDA, Novartis points out that: “a biosimilar, by definition of its approval, has successfully met FDA’s demanding standard of high similarity to a reference product and, further, the agency has concluded that the totality of the evidence demonstrates that there will be no clinically meaningful differences in terms of safety, purity and potency between it and the reference product.”
Imposing unique INNs on biosimilars would not improve any aspects of patient safety, pharmacovigilance or tracking, and would instead undermine the safe use of all biologics, it warns the agency.