After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the U.S. healthcare market, and the impact these products will have on new drug development and product pricing and marketing.
Novartis markets biosimilar filgrastim as Zarzio in 40 countries and claims to hold more than 50% of the global biosimilars market. With more follow-on biotech products under development, Sandoz has been a prime candidate to take the lead in navigating the new U.S. regulatory scheme for these therapies.
Payers have predicted more than $200 billion in biosimilars sales in the U.S. over the next ten years if versions of the 20 approved biosimilars in Europe come to market. But actual savings will depend on product prices, how biosimilars impact pharma contracting, and if providers consider new biosimilars as safe and effective alternatives to established therapies, observes Tanisha Carino of Avalere Health. Savings to payers, providers and consumers, she points out, also will be affected by the extent of branded and biosimilar competition. This application is really “the first key step in learning if competition will hold down costs.”
FDA will apply the same standards of safety, purity and potency to biosimilars and require full compliance with good manufacturing practices. But brand-name firms have been pressing for state policies that may inhibit biosimilar prescribing, and continued disputes over biosimilar names and patent issues may curb or delay market access.
Sandoz’ application evidently passed the first FDA test by demonstrating that it was sufficiently complete to be accepted for filing. If there are no major defects or questions about the clinical and manufacturing test data, approval should come in ten months. All parties will be watching closely to see what scientific and technical issues are raised by FDA reviewers, and how innovator firms respond to the potential for added competition.