BioSimilar – Page 4 – Policy & Medicine

FDA: Biosimilars Labeling Guidance

Update on Biosimilars US Regulation 1st Quarter 2016

FDA Offering Free Biosimilars CME Course

BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade BioSimilar, Congress Asks Tough Questions of FDA and CMS

Biosimilars Clinical Studies and Analytical Similarity Summit – Update on Biosimilars

Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes New Identifiers For All Biologic Products

Biosimilars: Abbvie Finds Fault with Zarxio Label, Submits Citizen Petition

District Court Denies Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

FDA Approves Sandoz’s Zarxio, The First Biosimilar Approved in the U.S.

FDA Accepts Apotex’s Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex