Biogenerics need a more rigorous approval process, FDA says

08/4/2011 | Reuters

Biosimilars require a regulatory pathway in which more data are analyzed and the "totality of evidence" is examined, FDA officials said in an article published in The New England Journal of Medicine. "Given the complex nature of biologics, it's unlikely that a 'one size fits all' systematic assessment of biosimilarity can be developed," agency officials said. The FDA plans to issue guidelines this year for seeking approval of such drugs.

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