There seems to be something of a battle brewing in the research and development of complex proteins, especially human growth hormones. The FDA punted on Sandoz's application for Omnitrop, a human growth hormone.
As noted in the article, Pfizer filed a Citizen Petition with the FDA, asking the FDA to deny Sandoz's application for Omnitrope (a follow-on of Pfizer's drug, Genotropin). Sandoz responded, saying the allegations were without merit and that its product was just fine as is. Last week, Pfizer responded to Sandoz's letter, again said that the FDA should deny the Omnitrop application or at least defer action until after the FDA's public hearing in September on guidance for follow-on biologics.
Stay tuned to see how the words keep getting slung around, and what the FDA comes up with after the hearings ....
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