Dosage Forms

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

Bipartisan Bill for Biosimiliars and Biogenerics Introduced in the House

Angie Drakulich was editorial director of Pharmaceutical Technology.

The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs.

Final Rule for Generic Reporting Withdrawn

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals (Marietta, GA) paid generic drug makers Watson Pharmaceuticals (Corona, CA) and Par Pharmaceutical Companies (Woodcliff Lake, NJ) to delay generic competition to Solvay's branded testosterone-replacement drug "AndroGel," a prescription pharmaceutical with annual sales of more than $400 million, according to an FTC press release.

FTC Files Complaint Against Generic Drug Makers

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

Merck Forms Follow-On Biologics Business; Emphasizes Emerging Markets

The European Commission (EC) published a preliminary report stating that competition in the pharmaceutical industry does not work as well as it should.

European Commission Report: Originators Block Generic Competition

During its roundtable discussion titled "Follow-On Biologic (FOB) Drugs: Framework for Competition and Continued Innovation," The Federal Trade Commission (FTC) discussed likely effects, patent issues, and regulatory exclusivity periods concerning FOBs.

GPhA Applauds FTC Biogenerics Roundtable while Biotechs Fall

The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.

Federal Report Outlines Cost Savings in Biosimilars Approval Pathway

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.

HHS Targets FDA's Generic Drug Reviews

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

To keep up with applications, FDA promotes new testing and administrative methods.

Generic Drugs for Everyone

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.