Masterarbeit
'Chemo-similars', a new challenge for regulatory affairs?!
Dr. Stefan Leyers (2011)
Language: English
Chemo-Similars could be defined as: A chemical medicinal product referring to an existing one and submitted to regulatory authorities for marketing authorization after the time of the data protection has expired for the original product. The structure and composition of the drug cannot be estimated fully by the up to date analytical measuring techniques. Thus changes to the drug substance may result in safety, quality and / or efficacy concerns.
Three examples for products which could be defined as Chemo-Similars were investigated regarding their handling within in the competent authorities of Europe and the United States: Gadolinium containing contrast agents, iron sucrose as an example for iron carbohydrate complexes, and Glatiramer acetate, a mixture of peptides with a high variability in composition.
A big difference could be observed via comparison of the European competent authorities and the FDA. While the FDA appears to be very strict and conservative regarding the authorization of Chemo-Similars, meaning that none has been approved yet, the European Union often handled and handles these medicinal products like normal generics and approved those medicinal products according to article 10 of Directive 2001/83/EC. However according to this investigation neither the European nor the United States approach seems adequate to cope with the quite new issue of Chemo-Similars.
Due to the similarity of Chemo-Similars to Bio-Similars a Bio-Similar like approach according to the European regulatory framework was suggested for the handling of Chemo-Similars. This pathway does not seem to be appropriate for all investigated drugs and has to be adapted on case-by-case basis.
However the United States regulatory framework does not even comprise such a biosimilar pathway, what makes a general consideration for a more or less global handling of Chemo-Similars in near future quite unlikely.
Pages: 48, Annexes: pages : 0