ABSTRACT
Generic drugs are an important component for meaningful health-care reform currently
being debated in the United States. Aside from defining the period of drug exclusivity,
however, there is a critical need to ensure that generics of biologic medicines (biosimilars)
are safe and effective. For low molecular weight heparins (LMWHs), the standard of
care for management of venous thromboembolism, their complex structure and polypharmacological
actions make producing a generic LMWH more challenging than a generic small molecule
medicine. Because biosimilar LMWHs will be used interchangeably with their branded
product, inherent variability between products could lead to important differences
in potency, safety, or effectiveness, including unanticipated immune responses. Awareness
of the specific problems associated with biosimilar LMWH development led to new recommendations
from several expert bodies. This article discusses the implications of these differences
for the production of biosimilar LMWHs and provides recommendations to address the
limitations in the pending U.S. Congress legislation, a well-intentioned undertaking
but one that must preserve the health and welfare of citizens who require these critical
care medications.
KEYWORDS
Biosimilar - generic - low molecular weight heparin - safety - thromboembolism
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Jeanine M WalengaPh.D.
Professor, Thoracic & Cardiovascular Surgery and Pathology, Cardiovascular Institute,
Building 110, Room 5226, Loyola University Medical Center
2160 S. First Avenue, Maywood, IL 60153
Email: jwaleng@lumc.edu
