Biosimilars: Does global development require multiple studies?

04/9/2012

Various countries have established legal and regulatory pathways to allow "copies" of an off-patent biotherapeutic product to be brought to market. However, unlike small-molecule generic drugs, these large, complex protein molecules cannot be absolutely identical to the original. Instead, a large-molecule copy drug must be demonstrated to be similar to a reference product by performing a side-by-side comparison to the originator molecule. Read the article. Get more free content like this by subscribing to BioPharm International.

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