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Why biosimilars should be interchangeable with biologics


The debate on the interchangeability of biosimilar drugs and the originator biological product must be informed and driven by the scientific data and regulatory opinion, rather than political or financial wishful thinking about the potential for controlling budgets or reducing spending. Unlike small molecule generics, biosimiliars are not identical to the originator and the scientific understanding of the effects of these small differences are not fully understood. In most cases the clinical efficacy and safety data underpinning biosimiliars is based on limited patient numbers and exposure times. In the absence of an equivalent extent of clinical safety data as the originator, or well designed interchangeability/ switching safety/ efficacy clinical studies, it is entirely justified to not to switch the treatment of existing patients between the originator and biosimiliars products or between different biosimiliars products

Posted date

30 JAN 2017

Posted time



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