Generic Biologics Bill’s Key Battleground May Be Senate Health Committee
This article was originally published in The Pink Sheet Daily
Executive Summary
Reintroduced legislation drops tax credits for development of follow-ons. Sponsors see PDUFA reauthorization as ideal vehicle.
You may also be interested in...
Generic Biologic Bill Needs Clinical Data Requirements, Sen. Hatch Says
At Senate hearing, co-author of ANDA legislation says that FDA should require clinical trials from sponsors seeking follow-on biologic approval.
Generic Biologic Bill Needs Clinical Data Requirements, Sen. Hatch Says
At Senate hearing, co-author of ANDA legislation says that FDA should require clinical trials from sponsors seeking follow-on biologic approval.
Indian Companies Ramping Up For Follow-On Biologics
Like Western companies, Indian drug makers are buying or forming alliances with biotechs to enrich their pipelines but with the added goal of ramping up to do what they currently do best: create generic versions of branded drugs