www.fdanews.com/articles/159617-gpha-petitions-fda-for-same-name-biosimilars
GPhA Petitions FDA for Same-Name Biosimilars
October 2, 2013
In an effort to avoid confusion that could jeopardize patient safety and access, biosimilars should have the same international nonproprietary name as the biologic they refer to, GPhA asserts in a citizen petition filed Sept. 17. Biosimilars have “no clinically meaningful difference from the reference product,” so they should have the same name, GPhA’s President and CEO Ralph Neas said.
Generic Line
Generic Line