No Six-Month Wait for Biosimilars After FDA Approval-US Supreme Court
The US Supreme Court last month (June 12, 2017) in Sandoz v. Amgen ruled unanimously in favor of generic that biosimilar companies will not have to wait an additional six months after FDA approval to launch their product. The case concern a biologic product filgrastim marketed by Amgen as Neupogen since 1991 and claims to hold patents on methods of […]