Generic clopidogrel–the medicines agency’s perspective
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 2
Abstract
A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety (AGES PharmMed) considered this issue and reached the conclusion that the generic clopidogrel products were in principle equivalent to the originator product with regard to safety and efficacy.
Authors and Affiliations
Christoph Baumgärtel
Keywords
Related Articles
- EP ID EP355165
- DOI 10.5639/gabij.2012.0102.019
- Views 116
- Downloads 0
Complex molecules – current developments
The pharmacological activity and toxicity of non-biological complex drugs (NBCDs) depends on their complex structure and composition. The regulatory approach leading to the registration of such drugs and their follow-on...
Biosimilarity of anticancer monoclonal antibodies in the clinic
The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, con...
First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013
Introduction: In recent years a new category of medicinal products, the non-biological complex drugs (NBCDs) emerged. They are distinct from both the small molecules and the biological therapeutics by being composed of n...
Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased ris...
Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered
To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and trace...