Healthy Skepticism Library item: 5557

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wick JY, Zanni GR.
Biogenerics: potential benefits and obstacles.
Consult Pharm 2006 Mar 01; 21:(3):208-12,

Abstract:

Stakeholders in the prescription drug process are familiar with the savings possible when generic substitution is available. When drugs that enjoy a large market share come off patent, multiple generic manufacturers usually are ready to market a lower-cost generic. Today, the fastest growing segment of the pharmaceuticals market is biologics. Although the patents for several costly and successful biologics have expired or will expire in the near future, no biogenerics have yet been approved. The scientific difficulties of replicating large sugar- and protein-based molecules and related safety issues represent obstacles to an abbreviated biologics approval process.

Keywords:
Biological Products* Drug Approval Drug Industry/organization & administration Drug Industry/standards Drugs, Generic* Humans Pharmacists Professional Role United States United States Food and Drug Administration/legislation & jurisprudence United States Food and Drug Administration/standards