FDA of­fers guid­ance on de­vel­op­ing biosim­i­lars

Modern Healthcare - - LATE NEWS -

The Food and Drug Ad­min­is­tra­tion is­sued draft guid­ance that out­line sci­en­tific and qual­ity is­sues with de­vel­op­ing drugs known as biosim­i­lars. The guid­ance also ad­dresses in­dus­try ques­tions about the im­ple­men­ta­tion of the Bi­o­log­ics Price Com­pe­ti­tion and In­no­va­tion Act, part of the Pa­tient Pro­tec­tion and Af­ford­able Care Act, which cre­ated an ap­proval path­way for biosim­i­lars, or fol­low-on bi­o­log­ics, which are generic ver­sions of pro­tein-based prod­ucts. The FDA said it ex­pects biosim­i­lars to be “highly sim­i­lar” to the bi­o­log­i­cal prod­uct that re­ceived ap­proval. “These draft doc­u­ments are de­signed to help in­dus­try de­velop biosim­i­lar ver­sions of cur­rently ap­proved bi­o­log­i­cal prod­ucts, which can en­hance com­pe­ti­tion and may lead to bet­ter pa­tient ac­cess and lower cost to con­sumers,” said Dr. Janet Wood­cock, di­rec­tor of the FDA’S Cen­ter for Drug Eval­u­a­tion and Re­search, in a news re­lease. The Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion said that com­pe­ti­tion from generic ver­sions of biosim­i­lars will help keep costs down for bi­o­logic medicines. “As proven with chem­i­cal pre­scrip­tion drugs, com­pe­ti­tion from gener­ics will be the most im­por­tant fac­tor in hold­ing down the cost of bi­o­logic medicines,” the GPHA said in a state­ment. Last month, the FDA sub­mit­ted rec­om­men­da­tions to Congress for the pro­posed Biosim­i­lar and In­ter­change­able Prod­ucts User Fee Pro­gram, which would raise money from drug man­u­fac­tur­ers to help cover the costs of re­view­ing drugs in ex­change for an ef­fi­cient ap­proval process.

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