Dawn of a new era: FDA approves first-ever biosimilar, Novartis/Sandoz's Zarxio
- The FDA has approved Novartis/Sandoz's Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen and used to prevent infection and improve immune function in patients undergoing cancer treatment.
- This is the first-ever U.S. approval for a biosimilar, and the approval signals the beginning of a better defined 351(k) pathway. However, U.S. policy surrounding biosimilars is still evolving.
- The nonproprietary designation of this product as "filgrastim-sndz" is a placeholder, until there is a more concrete policy around biosimilar naming conventions.
Biosimilars have officially come to America.
The U.S. is a little late to this particular party. Zarxio, which Sandoz markets as Zarzio in other countries, is already approved in more than 40 other markets. That's part of the reason why Zarxio was approved in the U.S. despite some lingering haziness in the 351(k) pathway—there have already been extensive safety studies on the product done in many other nations.
Zarxio is approved for all the same indications as Neupogen. Analysts expect biosimilars to cut anywhere from 20% to 30% off of branded biologics' costs, although there is still some debate about how much those savings may get passed on to patients and whether the discounts will be as steep for non-specialty biologics.