Genentech Wants to Block FDA Use of Drug Data for Biogenerics Guidance

Drug Industry Daily
KEYWORDS BIO / FDA
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In a citizen petition opposing FDA approval of Sandoz’ follow-on human growth hormone Omnitrope, biotechnology firm Genentech asked the agency to notify drugmakers of any potential use of their drugs’ safety and efficacy data, a move that would stymie the agency’s efforts to draft a guidance for the manufacture of follow-on biologics.

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