Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine whether notice of commercial marketing under Subsection of the Biologics Price Competition and Innovation Act is legally effective if given prior to FDA approval, and whether, in any event, the notice provision can be enforced by an injunction that delays market entry of a biosimilar by 180 days. This case centers around Sandoz's FDA-approved biosimilar ZARXIO, which is intended to compete at a lower price-point with Amgen's brand-name NEUPOGEN .
A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen's Neulasta , a long-acting version of Amgen's Neupogen , but have encountered hurdles so far both in the U.S. and Europe. Amgen's Neulasta is a treatment that is used to help cancer patients on chemotherapy fight off infections.
On yesterday's earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta product to face biosimilar completion in the U.S. by the end of the year. According to Amgen Executive Vice President and CFO David Meline, Amgen is operating under the assumption of "biosimilar competition against Neulasta commencing in the fourth quarter" of 2017.
The FDA's final verdict on how biological drugs should be named, revealed Thursday, January 12, could affect the makers not only of biosimilars but also of all future biologicals and - remarkably - those that have already been approved and are on the market. The crux of the agency's guidance is that all biologicals should add to their non-proprietary names a hyphenated suffix composed of four random letters.