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The Burrill Report (September 27, 2010): How Will the FDA Decide A Biosimilar is Enough Like the Real Thing (.MP3,16.61 Mb)
The U.S. Food and Drug Administration plans to hold two days of public hearings in November to discuss how it will review so-called biosimilars, alternative versions of biologics that have gone off-patent. Unlike generic drugs, which are copies small molecules that are chemically-synthesized, the molecular complexity of biologics and the fact that they are produced by living cells raises challenges for the regulator on how to determine that a biosimilar is as safe and efficacious as the original product. We spoke to Kay Holcombe, senior policy advisor for Genzyme, about the upcoming hearings, what the most contentious issues will likely be, and why there’s more at stake for the industry than just a possible financial hit from lower priced competition.
September 24, 2010
http://www.burrillreport.com/article-how_will_the_fda_decide_a_biosimilar_is_enough_like_the_real_thing_.html
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How Will the FDA Decide A Biosimilar is Enough Like the Real Thing
Podcast: September 27, 2010TELL US WHAT YOU THINK
COMMENTS
MichaelRS September 27, 2010
Just to balance views, it might be interesting to listen to Biotecon, Ranbaxy, Dr. Reddy's, Sandoz, Wockhard and the likes, who they currently monitor the biosimilariness of their biosimilars/biogenerics. I would argue that they have a whole arsenal of tools they use to describe their products. It appears that the analytical tools are further advanced than the public policy groups knowledge of it.
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