The biopharma giant has filed a Citizen’s Petition with the US Food and Drug Administration (FDA) urging the agency to require that a biosimilar - once approved in the US - share the same INN as the reference product, following the lead of Mylan, the GPhA (Generic Phrarmaceutical Association) and, last week, Hospira.
Novartis spokesperson Julie Masow told Biopharma-Reporter.com the firm has been advocating for maintaining the current INN system for the last several years and has petitioned the FDA now to “provide clarity on this issue” at a time when discussion around modifying the INN system for biosimilars is ongoing.
“We believe that a few originator companies are trying to modify the well-established INN to cast unnecessary doubts around biosimilars,” she said, and within “public statements, these companies and their trade associations have positioned this as a pharmacovigilance issue.”
“As an originator company, we feel this argument does not have any merit as traceability of biosimilars does not require new or additional non-proprietary names.”
Furthermore, within the petition, the Switzerland-headquartered firm argued that changing the INN would undermine the “safe and rational use of all biologics” and “introduce unnecessary confusion into the healthcare system.”
However, Biopharma-Reporter.com also spoke to Andrew Womack Director of Science and Regulatory Affairs at industry group, BIO (Biotechnology Industry Organisation), who told us quite the opposite.
From a patient safety perspective “all biologics should have unique names,” he said, “because by definition they are manufactured in living systems and therefore there is some level of variability and the naming should reflect that.”
BIO has long been an advocate of different INNs of biologics, sending a joint open letter with the Pharmaceutical Research and Manufacturers of America (PhRMA) in June 2012 to FDA Commissioner, Margaret Hamburg.
Though BIO has no set mechanism yet, Womack suggested one alternative way to name biosimilars to avoid confusion would be for biologics to have a common stem for each specific class, and a differntiator for the bioequivalent.
Earlier this week, BIO published another statement once again opposing the same INN for biosimilars on the basis that biosimilars are not the same as the branded equivalent.
This was sent in response to a letter sent by six US Senators to Hamburg raising concerns about biosimilar nomenclature. In this case, Congress decided to leave any decision in the hands of the FDA.
However, one of the arguments used by Novartis is that such discussion is undermining “FDA's years of practice in reviewing and approving manufacturing changes of originator biologics without requiring new INNs.”
Womack said this was not the case, and the FDA itself has already “noted biosimilars will be highly similar but not the same” as the branded drug. Instead this debate should be seen as an “exchange of ideas” based on scientific concerns.
Biopharma-Reporter.com contacted the FDA directly to gauge its position on INNs. Spokesperson Lisa Kubaska tols us: “The FDA is currently considering the appropriate naming convention for biosimilar and interchangeable products licensed under the pathway established by the BPCI Act enacted as part of the Affordable Care Act.
“The FDA is carefully reviewing and considering the comments submitted to the biosimilar draft guidance and public hearing dockets,” and “will take into consideration all comments as we move forward in finalizing the draft guidance documents and in developing future policies regarding biosimilar and interchangeable products, including naming.”