Priority Review Voucher Plan's Looming Sunset Shouldn't Dissuade Sponsors – FDA
This article was originally published in The Pink Sheet Daily
Although FDA will be barred from issuing new rare pediatric disease priority review vouchers in March absent a legislative extension, agency is still encouraging sponsors to file designation requests.
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The recent series of sales of priority review vouchers at ever-higher prices has transformed what had seemed to be a failed incentive model into a hot topic. However, one key stakeholder is not celebrating the recent developments: the FDA review teams that have to deliver the faster paced reviews continue to have strong reservations about the program.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.