Biosim­i­lar in­spec­tions still lag­ging as the FDA looks to clear its back­log

While biosim­i­lars are see­ing greater recog­ni­tion from the fed­er­al gov­ern­ment, most no­tably HHS’ Of­fice of the In­spec­tor Gen­er­al high­light­ing their cost-sav­ing abil­i­ties, the in­spec­tion of man­u­fac­tur­ing sites pro­duc­ing them is still lag­ging.

Ju­liana Reed, the ex­ec­u­tive di­rec­tor for the Biosim­i­lars Fo­rum, told End­points News in an in­ter­view that 90% of in­spec­tions at man­u­fac­tur­ing sites for drugs and gener­ics have con­tin­ued apace, but for biosim­i­lars, the rate has dropped to 67% as these in­spec­tions are a low­er pri­or­i­ty.

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