Dosage Forms

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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.

Sandoz Wins EU Approval, US Progress for Biogeneric Product

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

FDA Proposes Question-Based Review System for Generics

New Guidance May Speed Generic Approvals

Arvind K. Bansal is an associate professor at the National Institute of Pharmaceutical Education and Research, Sector-67, Phase-X, S.A.S. Nagar, Punjab 160062, India, tel 191 0 172 2214682 87, fax 191 0 172 2214692.

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 Role of Reverse Engineering in the Development of Generic Formulations

The Empire Strikes Back: Innovators Releasing Generic Drugs