FDA decision could mean more competition for Amgen
Amgen is bracing for yet another drug to compete with its biologic medications.
A U.S. Food and Drug Administration advisory panel is scheduled to consider approval Wednesday of a biosimilar created by Sandoz, Novartis’ generic arm. The panel will advise the FDA, which makes the final call.
Sandoz’s GP2015 would mark the fourth biosimilar the company has developed to compete with Amgen biologics. Last September, Sandoz became the first company to launch a biosimilar in the U.S. after receiving FDA approval in March 2015 for Zarxio, a biosimilar version of Amgen’s cancer medication Neupogen.
According to Sandoz’s website, the company has at least two other biosimilar versions for Amgen drugs in development. They include one for Amgen’s anemia medication Epogen and its blockbuster cancer treatment Neulasta.
The estimated impact on the high cost of biologics, some of which can cost several thousands of dollars a month, has varied. Initial projections when Zarxio was approved had the drug being sold at a 30% to 35% discount to Neupogen.
Once Zarxio was officially launched, the listing price reflected only a 15% discount from the price of Neupogen.
The FDA advisory panel Tuesday also will consider the application for approval of Amgen’s own biosimilar version of AbbVie’s best-selling arthritis drug Humira.