Re: Biogenerics
>Theresa L. Gerrard, a consultant to the Generic Pharmaceutical Association, said that biotechnology companies often tweak their processes but do clinical trials only if analytical tests show the drugs differ, she said. Moreover, she added, perfect replication is unnecessary because the drugs that Genentech produces also vary slightly from lot to lot. ''We're not asking for a lower standard,'' Dr. Gerrard said. ''We're asking to use the standard that has been in place at the F.D.A. for 15 years.'' <
Exactly! Much of what is emanating from Big Bio these days is simply anti-generic propaganda. If you applied the arguments bring promulgated by Big Bio literally, every biopharmaceutical would need a new clinical trial every time there was a new batch.
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