Generic Drugs/Biosimilars

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.
Apr 14, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The Empire Strikes Back: Innovators Releasing Generic Drugs
Apr 02, 2005
Pharmaceutical Technology
Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.
Feb 24, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Novartis to Expand Generics Hold
Feb 03, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Generic Drug for HIV/AIDS Gains FDA's Tentative Approval
Feb 02, 2005
Pharmaceutical Technology
The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.
Jul 02, 2003
Pharmaceutical Technology
Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.
Dec 02, 2002
Pharmaceutical Technology
Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.
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