FDA+ roundup: As­ses­sor finds FDA's new biosim­i­lar re­view mod­el makes the process more pre­dictable

As Con­gress preps to re-au­tho­rize the next round of biosim­i­lar user fees be­fore the end of Sep­tem­ber, an in­de­pen­dent as­ses­sor’s fi­nal re­port from Bs­U­FA II shows that the FDA’s new re­view process for biosim­i­lar ap­pli­ca­tions did en­hance the pre­dictabil­i­ty of the re­views and helped FDA con­duct more first-cy­cle re­views more ef­fi­cient­ly.

With an ad­di­tion­al two months to com­plete the biosim­i­lar re­views un­der Bs­U­FA II, FDA’s first-cy­cle ap­proval rate has been high­er in Bs­U­FA II when com­pared to pre­vi­ous years, al­though it’s un­clear if that dif­fer­ence is sta­tis­ti­cal­ly sig­nif­i­cant, ac­cord­ing to the fi­nal re­port from East­ern Re­search Group, an in­de­pen­dent con­trac­tor en­list­ed to as­sess FDA’s biosim­i­lars pro­gram.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER