It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's ($AMGN) Neupogen from Novartis' ($NVS) generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
Friday, U.S. regulators green-lighted Zarxio for all 5 indications on white-blood-cell-booster Neupogen's label, a move Sandoz's global head of biopharmaceuticals, Carol Lynch, called a "significant milestone for the United States healthcare system."
"We are honored to be the first company to successfully work with FDA to navigate the U.S. biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the U.S.," she said in a statement.
|FDA Commissioner Margaret Hamburg|
But according to a recent study from the Tufts Center for the Study of Drug Development, some key hurdles stand between Zarxio's approval and success in the marketplace--physician safety concerns among them. Lack of familiarity with biosimilars could leave physicians hesitant to prescribe them, professor and study author Joshua Cohen said in a statement--as has been the case in Europe, which has already seen 17 biosimilar approvals since 2006.
FDA Commissioner Margaret Hamburg did her best to dispel any concerns in the agency's approval announcement, assuring patients and the healthcare community that they "can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards."
|Novartis CEO Joe Jimenez|
But even Novartis chief Joe Jimenez knows things won't happen overnight for Zarxio. He expects the tipping point for biosimilar drugs--expected to be priced about 20% to 30% below their pricey reference products--to come in 2020, after the market has had some time to get used to them and the FDA has figured out just how to regulate them.
At that point, "you're going to see a big impact," he said last August.
Drugmakers won't be the only ones feeling that impact. Express Scripts figures biosimilars will help the U.S. healthcare system shave some $250 billion off its spending over the next 10 years.
- read Novartis' release
- see the FDA's release
- get more from the Tufts Center for the Study of Drug Development
Special Report: Top 10 generics makers by 2012 revenue - Novartis (Sandoz)