Last Friday, the FDA approved its first biosimilar drug, Zarxio. The drug is produced by Sandoz, a division of Novartis, and is a close copy of the biologic drug Neupogen, which is used to help prevent infections in cancer patients undergoing chemotherapy.
According to the FDA,
A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.
An FDA panel unanimously recommended Zarxio’s approval in January 2015. The drug was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because the FDA lacked a regulatory pathway for biosimilars.
Amgen, the manufacturer of Neupogen, is seeking an injunction to stop the sale of Zarxio, claiming that Sandoz’s generics division declined to participate in patent disclosure procedures (more on the legal issues here). The two companies will be in federal court in California on March 13, 2015, and the result of this case will likely set a precedent for other biosimilar manufacturers. Sandoz said it would not start selling Zarxio until a decision was made on the injuction or April 10, 2015, whichever comes first.