Abstract
The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of “similar biological medicinal product” that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union. This different legal basis determines directly the technical requirements to obtain a marketing authorisation. Therefore, the chemical/biological, non-clinical and clinical requirements to demonstrate therapeutic equivalence are different in these two Regulatory Authorities, FDA and EMA. Consequently, the possible conditions of use are different. In the United States the products approved as generics by the FDA are considered interchangeable to the Reference Listed Drug. In contrast, the EMA legislation only deals with the approvability or prescribability of the medicines and it is a national / regional decision of the member States to consider these biosimilar products as interchangeable or not.
Keywords: Bioequivalence, biosimilars, generic, interchangeability, low molecular weight heparins, regulatory science
Current Drug Discovery Technologies
Title:Regulatory Considerations for Generic or Biosimilar Low Molecular Weight Heparins
Volume: 9 Issue: 2
Author(s): Alfredo Garcia-Arieta and Antonio Blazquez
Affiliation:
Keywords: Bioequivalence, biosimilars, generic, interchangeability, low molecular weight heparins, regulatory science
Abstract: The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of “similar biological medicinal product” that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union. This different legal basis determines directly the technical requirements to obtain a marketing authorisation. Therefore, the chemical/biological, non-clinical and clinical requirements to demonstrate therapeutic equivalence are different in these two Regulatory Authorities, FDA and EMA. Consequently, the possible conditions of use are different. In the United States the products approved as generics by the FDA are considered interchangeable to the Reference Listed Drug. In contrast, the EMA legislation only deals with the approvability or prescribability of the medicines and it is a national / regional decision of the member States to consider these biosimilar products as interchangeable or not.
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Cite this article as:
Garcia-Arieta Alfredo and Blazquez Antonio, Regulatory Considerations for Generic or Biosimilar Low Molecular Weight Heparins, Current Drug Discovery Technologies 2012; 9 (2) . https://dx.doi.org/10.2174/1570163811209020137
DOI https://dx.doi.org/10.2174/1570163811209020137 |
Print ISSN 1570-1638 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6220 |
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