Clinical efficacy studies should not be the default for biosimilars development, FDA says

As the FDA and oth­er reg­u­la­tors look to stream­line the de­vel­op­ment of new biosim­i­lars fur­ther, the US agency is look­ing to in­still in its for­eign coun­ter­parts that clin­i­cal ef­fi­ca­cy stud­ies (CES) should not be manda­to­ry for all new biosim­i­lars to come to mar­ket.

A re­cent work­shop for FDA and in­dus­try, in ad­di­tion to an­oth­er closed-door meet­ing of about 300 reg­u­la­tors, re­vealed a “lit­tle bit sur­pris­ing” con­clu­sion that the ma­jor­i­ty of drug reg­u­la­tors think clin­i­cal ef­fi­ca­cy stud­ies should be a de­fault re­quire­ment for all new biosim­i­lars, Sarah Yim, di­rec­tor of FDA’s Of­fice of Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars, said at the gener­ic drug in­dus­try group’s GRx+Biosims con­fer­ence in Bethes­da, MD, yes­ter­day.

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