Amgen Sues Sandoz to Block Biosimilar Application of Neupogen
Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development.
Biosimilar applications are supposed to provide the reference drug manufacturer with its application and information on how the biosimilar will be produced, but Sandoz failed to do so, Amgen charges in the lawsuit.
Earlier this year, the FDA accepted Sandoz’s application for a biosimilar of the chemotherapy side effects drug Neupogen (filgrastim), becoming the first application accepted under a pathway created by Congress more than four years ago.
The FDA pathway requires a biosimilar applicant to disclose its BLA and manufacturing information to the reference drug manufacturer within 20 days of filing.
“That disclosure allows the innovator to assess which patents the biosimilar applicant’s activities could infringe and, critically, to start a process that will allow the innovator to bring its patent claims before the applicant begins selling an infringing product,” Amgen said.
Sandoz offered to let Amgen see its BLA but not the manufacturing information, an offer Amgen declined because it didn’t meet the full regulatory requirement, the company said. In addition, Sandoz told Amgen a day after that 20-day deadline lapsed that it would not comply with the requirement at all, according to the lawsuit filed Oct. 24 in the U.S. District Court for the Northern District of California.
Amgen alleges that the failure to provide the information was an attempt by Sandoz to avoid patent litigation on the Neupogen biosimilar.
The FDA must make a decision on Sandoz’s application by May 2015 (Generic Line, July 29).
Amgen asked the court to compel the agency to not approve a biosimilar of Neupogen until the drugmaker has received enough time to review the BLA and manufacturing information.
Neupogen is intended to help lower infections in chemotherapy patients, and is Amgen’s top-selling product. The drug generated $1.4 billion in sales in the third quarter of this year, according to Amgen’s latest financial report. — Robert King