US biosimilar era officially dawns as Novartis' Zarxio launches Thursday
- Despite Amgen's efforts to prevent sale of Novartis/Sandoz's Zarxio, a biosimilar of Neupogen (a white blood cell-boosting therapy for cancer patients undergoing chemotherapy), the drug can be legally sold in the U.S. as of Thursday after an appellate court ruled on Wednesday that Amgen could not block its imminent sale.
- Amgen is the brand manufacturer for Neupogen (filgrastim), which grosses roughly $1.2 billion per year.
- The standoff between Amgen and Sandoz (the generics division of Novartis) is part of the process of seeking clarification around the federal regulations which goven biosimilars. Zarxio officially hits the U.S. market on Thursday at a 15% discount to original Neupogen.
Ready, set, go!
The market is ready for Zarxio, a drug that was originally approved by the FDA in 1991 and is used to help increase cancer patients' white blood cell counts and ward off infections. Neupogen costs about $3,000 per chemotherapy cycle (before accounting for discounts and rebates), but Zarxio will be available at a 15% discount.
That's not quite as hefty a price cut as biosimilars provide in other countries. For instance, looking at Europe (which has had biosimilars for 10 years) as a guide, insurers and patients sometimes see drug discounts in the 30% to 50% range for biosimilar copies.
While the first biosimilar has now debuted in America, the regulatory and legal issues surrounding the "generic biologics" are far from being settled. In fact, the FDA is already receiving major industry pushback on its new draft guidance for naming biosimilars.
The proposal, which includes an FDA-designated suffix for biosimilars, has earned the ire of organizations like the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council, which insist that "biologics and biosimilars should be required to have the same International Nonproprietary Name (INN) with no added 'FDA-designated suffix.'"
Make sure to check out our interview series with Dr. Bert Liang, head of the Biosimilars Council and CEO of the biosimilar development firm Pfenex Inc., on innovation in this therapeutic field and some of the most important questions remaining about the age of biosimilars in the U.S.