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Journal of Clinical & Experimental Pathology | ISSN: 2161-0681 | Volume 8
Breast Pathology and Cancer Diagnosis
6
th
World Congress and Expo on
July 25-26, 2018 | Vancouver, Canada
Medicinal Chemistry and Rational Drugs
20
th
International Conference on
&
Development registration of biosimilars to global regulatory standards
Ash Ramzan
Woodley BioReg Ltd, UK
O
utlining the importance of biosimilars, the current legislation, commercial and technical/scientific status of biosimilars in
the EU this presentation outlines the growing potential of products within this market. There will be examples of currently
approved biosimilars, the basis of their approval and details of the developmental pathway differences between innovator products
and biosimilars. The process for the determination of biosimilarity and details of the approaches used successfully will be shared. A
knowledge-based approach to biologics testing is described that uses analytical, bioassays, and preclinical tests to minimise the need
for extensive clinical evaluation therefore reducing the cost of development. Some of the limitations including regulatory, scientific,
and quality concerns will be highlighted with particular emphasis on interchangeability and an overview of the requirements for on-going
comparability and conformance.
enquiry@woodleybioreg.comJ Clin Exp Pathol 2018, Volume 8
DOI: 10.4172/2161-0681-C3-052