Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Meitheal Pharmaceuticals can begin preparations for a seminal moment, the firm’s first marketed US biosimilar, as it snapped up rights to Humira rival Yusimry from Coherus BioSciences.

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.