Biogenerics: potential benefits and obstacles.
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.
Wick
Jeannette Y
JY
National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Zanni
Guido R
GR
D001688:Biological Products; D017277:Drug Approval; D004345:Drug Industry / Q000458:organization & administration / Q000592:standards; D016568:Drugs, Generic; D006801:Humans; D010595:Pharmacists; D024382:Professional Role; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
D001688:Biological Products; D016568:Drugs, Generic