Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
In an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues are...more