Words Of Wisdom For Biosimilar Developers
This article was originally published in RPM Report
FDA has learned a lot from its biosimilar meetings and sponsor discussions so far – including the areas sponsors struggle with and how others might improve their understanding going forward.
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As FDA nears the first review deadlines for biosimilar applications, some policy points are coming into sharper focus. Clinical studies for immunogenicity sound like a benchmark requirement, while extrapolation of indications also seems like the agency’s default position.
The Biotechnology Industry Organization submitted the following letter in response to this article, after it was published on-line in July.
An abbreviated pathway for follow-on biologics was one of the biggest issues for biotech investors in the legislative debate over health care reform. Two years after enactment, FDA is still waiting for the first application.