FDA Biosimilar Guidances Stir Innovator Worries About BLA Exclusivity, Trade Secrets
Brand pharma/biotech stakeholders say that BLA sponsors should not have to request and justify the award of 12 years of innovator exclusivity, as FDA’s draft guidance suggests. They also raise concerns about disclosure of BLA trade secrets, with Abbott asserting that approval of biosimilars that reference products licensed before March 2010 would constitute a “taking.”
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New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.
At least nine complaints have been filed against the agency since March, most involving market exclusivity claims; lawyers expect innovators will be pursuing more cases as patents expire and biosimilars emerge.
The assessment technique has mostly been seen as a confirmatory, not exploratory, process, but FDA will ask its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to weigh in on research needed to correlate in vitro dissolution testing with in vivo drug performance.