Generic Drugs/Biosimilars

Jun 29, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Last week, the Generic Pharmaceutical Association (GPhA Arlington, VA) praised a proposal by the Senate Agricultural Appropriations Subcommittee that, if approved, would provide $10 million in additional funding for the US Food and Drug Administration?s (Rockville, MD) Office of Generic Drugs.
Apr 20, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.
Apr 06, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
FTC Plans to Study Competitive Impacts of Authorized Generic Drugs
Mar 24, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
BMS, Sanofi-Aventis Settle Over Generic Plavix
Mar 09, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
GSK Loses Bid to Block Generic "Flonase"
Nov 23, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
GSK Study Questions Bioequivalency of Generic Cold Sore Creams
Oct 20, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic
Sep 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
New Guidance May Speed Generic Approvals
Sep 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA Proposes Question-Based-Review System for Generics
Aug 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence—the most critical development area.
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