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Table summarizes all the immunological and cardiovascular serious adverse drug reactions reported in EudraVigilance as of January 1 st 2014 for the biosimilar epoetins currently on the EU market.
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Extrapolation to clinical indications for which the reference product has received CDSCO approval is not allowed.
This paper will review current and future use of biosimilars in oncology, regulatory aspects of biosimilar approval, and current and future impact of these agents on cancer drug expenditure.
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