FDA panel to weigh first biosimilar application
While the courts are working out patent resolution procedures for biosimilars, Sandoz's application to market a biosimilar version of Amgen's cancer drug Neupogen has been thoroughly vetted and seems to have made its case for biosimilarity.
In a 120-page brief issued by FDA's Oncological Drugs Advisory Committee, the panel finds no clinically meaningful differences between Sandoz's Zarzio (filigrastim), the first US biosimilar biologic application (BLA) to be reviewed by the FDA, and Amgen's Neupogen. It is providing recommendations to FDA on the drug Jan 7.
"Based on the totality of the evidence presented, Zarzio has demonstrated its biosimilarity to Neupogen. Analytical methods confirm the products, for all intents and purposes, are the same," the brief says.
FDA raised an issue of “slightly lower protein content” measurements in Zarzio commercial lots compared to Neupogen, but concluded based on additional data the commercial and clinical product was the same strength as the originator, writes Evercore ISI analyst Mark Schoenebaum in an investors' note.
The committee has focused on the biosimilar designation and not on the higher bar of interchangability, Schoenebaum writes, noting “on the point of biosimilarity, the FDA concludes that the ‘Applicant's data meets the requirement for a demonstration of no clinically meaningful differences' . . . in terms of safety, purity, and potency.”
Under the Biologics Price Competition and Innovation Act (BPCIA), products can be approved as biosimilar or as interchangable biosimilars. FDA requires a two-step process, first approval of biosimilarity, then in a subsequent submission, for interchangability. Biosimilar products have to be shown as interchangeable before they can be automatically substituted at a pharmacy. With its BLA for Zarzio, the Novartis Group company is seeking approval only for the biosimilar designation.
Besides equivalence, safety and efficacy demonstrated in its US clinical trial program, Zarzio has been marketed in Europe and other countries since 2009 with over 7.5 million days of patient exposure, demonstrating its clinical safety and efficacy, the committee's brief notes.
An $850 million product in the US, Neupogen has been challenged by Teva's Granix which has 15% market share per IMA data, with only one of 5 Neupogen indications, writes Evercore ISI analyst Umer Raffat.
As Sandoz is going for all five indications on Neupogen's label, “the main question for the meeting is whether to approve Zarzio for each of the five indications of Neupogen,” Schoenebaum writes.