Generic Drugs

In a move to strengthen its position in Western generic drug markets, Ranbaxy Laboratories Ltd. (Gurgaon, Haryana, India) acquired the Mundogen generic drug business of GlaxoSmithKline (GSK, London, England) in Spain, through Ranbaxy's Spanish subsidiary, Laboratorios Ranbaxy S.L.

Does the competition from authorized generics really help lower drug prices and boost healthcare savings?

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.

The US Food and Drug Administration (Rockville, MD) approved the first generic versions of "Zocor" (simvastatin), the anticholesterol drug by Merck & Co., Inc. (Whitehouse Station, NJ).

Pfizer, Inc. (New York, NY) reports the United Kingdom's Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in "Lipitor."

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.

FTC Plans to Study Competitive Impacts of Authorized Generic Drugs

BMS, Sanofi-Aventis Settle Over Generic Plavix

GSK Loses Bid to Block Generic "Flonase"

GSK Study Questions Bioequivalency of Generic Cold Sore Creams

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

FDA Proposes Question-Based-Review System for Generics

New Guidance May Speed Generic Approvals

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.

The Empire Strikes Back: Innovators Releasing Generic Drugs

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

Novartis to Expand Generics Hold

Generic Drug for HIV/AIDS Gains FDA's Tentative Approval

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.

Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.