Development of generic low molecular weight heparins: a perspective.
It is clear that the introduction of generic versions of low molecular weight heparins (LMWHs) is inevitable; however, it is important that the generic products are manufactured in strict compliance with the manufacturing specification of the branded product. Furthermore, regulatory agencies should require additional data on the chemical biologic, pharmacologic/toxicologic, and dose-response relationship in specific settings. Although there is strong opposition to stop the introduction of these drugs, their development will reduce cost and permit availability to all patients who need them. Some objective guidelines for the proper development of these drugs are needed. Only expert groups and advisory panels to the regulatory bodies can develop these guidelines.
Fareed
Jawed
J
Department of Pathology, Loyola University Chicago, 2160 South First Avenue, Maywood, IL 60153, USA. jfareed@lumc.edu
Leong
Wendy
W
Hoppensteadt
Debra A
DA
Jeske
Walter P
WP
Walenga
Jeanine
J
Bick
Rodger L
RL
D017277:Drug Approval; D016568:Drugs, Generic; D006495:Heparin, Low-Molecular-Weight / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D006495:Heparin, Low-Molecular-Weight