Groups seek clar­i­ty on in­ter­change­abil­i­ty in Bs­U­FA III

Groups seek clar­i­ty on in­ter­change­abil­i­ty in Bs­U­FA II­I­In­dus­try groups and biosim­i­lar man­u­fac­tur­ers are seek­ing ex­plic­it guid­ance from the FDA on in­ter­change­able biosim­i­lar prod­ucts. The com­ments were made to the agency as part of the reau­tho­riza­tion process for Biosim­i­lar User Fee Act (Bs­U­FA III) pro­gram.

The rec­om­men­da­tions for im­prove­ments in the third it­er­a­tion of FDA’s biosim­i­lars re­view pro­gram were made as part of a pub­lic dock­et opened by FDA. The agency al­so re­cent­ly held a pub­lic meet­ing to kick off the reau­tho­riza­tion process for Bs­U­FA III, which will be­gin in FY 2023 and run through FY 2027.

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