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Semin Thromb Hemost 2011; 37(3): 322-327
DOI: 10.1055/s-0031-1274515
© Thieme Medical Publishers

Low Molecular Weight Heparins Differ Substantially: Impact on Developing Biosimilar Drugs

Jeanine M. Walenga1 , Craig M. Jackson2 , Craig M. Kessler3
  • 1Loyola University Medical Center, Maywood, Illinois
  • 2Coagulation Diagnostics, San Diego, California
  • 3Georgetown University Medical Center, Washington, DC
Further Information

Publication History

Publication Date:
31 March 2011 (online)

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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