Tale Of Two Pathways: Follow-On Biologics Move Forth In EU, Stall In U.S.
Executive Summary
The European Medicines Agency's endorsement of Sandoz' human growth hormone Omnitrope could put further pressure on U.S. regulators to develop an approval pathway for follow-on biologics
You may also be interested in...
Canada Biosimilars Proposal Requires Extra Studies To Show Substitutability
Substitution of a biosimilar for its reference brand product would not be automatic under the framework proposed by Health Canada for approving what it calls "subsequent entry biologics.
Canada Biosimilars Proposal Requires Extra Studies To Show Substitutability
Substitution of a biosimilar for its reference brand product would not be automatic under the framework proposed by Health Canada for approving what it calls "subsequent entry biologics.
EU Biosimilar Guidance Offers Window To Bypass Comparative Trials
Manufacturers seeking regulatory approval of a follow-on biologic in the EU may be able to forgo clinical comparability trials under certain conditions, according to final guidelines on similar biologics issued by the European Medicines Agency March 8