Spe­cial re­port: FDA over­sight of 'biosim­i­lars' fac­ing com­plaints

Safety, costs among the is­sues to be weighed as FDA grap­ples with craft­ing an ap­proval process for generic ver­sions of bi­o­log­i­cal medicines

Modern Healthcare - - Front Page -

The spe­cific ap­proach that the U.S. Food and Drug Ad­min­is­tra­tion takes in defin­ing the reg­u­la­tory ap­proval process for generic ver­sions of bi­o­log­i­cal med­i­ca­tions could de­ter­mine if such a mar­ket ever launches in this coun­try.

The fed­eral agency jumped into the com­plex is­sue this year when it be­gan to craft guid­ance for de­ter­min­ing the safety and ef­fec­tive­ness of generic ver­sions of the pro­tein-based drugs, also known as biosim­i­lars or fol­low-on bi­o­log­ics, as called for in the Pa­tient Pro­tec­tion and Affordable Care Act. The agency has not spec­i­fied what its process will re­quire but health­care ex­perts ex­pect it to ad­dress test­ing re­quire­ments and whether, and to what ex­tent, datashar­ing is re­quired be­tween brand-name and generic man­u­fac­tur­ers.

The FDA’s pro­posed guid­ance on an ap­proval path for biosim­i­lars—ex­pected as early as this sum­mer—was au­tho­rized un­der a sec­tion of the 2010 re­form law called the Bi­olog- ics Price Competition and In­no­va­tion Act. Sup­port­ers of that mea­sure say it was needed to lower the cost of bi­o­log­i­cal drugs, which range from in­sulin to cancer treat­ments, and are gen­er­ally more ef­fec­tive and more costly than chem­i­cal phar­ma­ceu­ti­cals.

Both brand-name ver­sions of those drugs and bi­o­log­ics that are sim­i­lar to gener­ics were pre­vi­ously ap­proved un­der an iden­ti­cal costly and lengthy process.

But meet­ing ex­ten­sive re­quire­ments in a new process could cost too much and take too long to make the de­vel­op­ment of biosim­i­lars worth­while, ac­cord­ing to some.

“In the end, the amount of work that will be re­quired in a biosim­i­lar path­way will have a pretty di­rect im­pact on the mar­ket at­trac­tive­ness of pro­duc­ing biosim­i­lar prod­ucts in dif­fer­ent ther­a­peu­tic ar­eas and for dif­fer­ent dis­eases,” says Terry Hisey, vice chair­man and life sci­ences leader at con­sul­tancy Deloitte.

The concern that the FDA will de­velop overly bur­den­some reg­u­la­tory re­quire­ments and smother the U.S. biosim­i­lars mar­ket in its in­fancy is a concern shared by some pa­tient ad­vo­cates and mem­bers of Congress.

“If the hur­dles are too high then it will re­ally limit the avail­abil­ity of these med­i­ca­tions,” says Paul Brown, gov­ern­ment re­la­tions man­ager for the Na­tional Re­search Cen­ter for Women & Fam­i­lies, a not-for-profit, lib­eral health ad­vo­cacy or­ga­ni­za­tion based in Wash­ing­ton.

Sen. Bernie San­ders (I-Vt.) wrote to the FDA in 2010 that an ag­gres­sive reg­u­la­tory process would in­ter­fere with the pur­pose of the biosim­i­lar ap­proval law. In par­tic­u­lar, San­ders wrote, any re­quire­ment that generic bi­o­logic mak­ers con­duct their own tri­als would vi­o­late med­i­cal ethics, specif­i­cally the Dec­la­ra­tion of Helsinki on eth­i­cal prin­ci­ples for med­i­cal re­search in­volv­ing hu­mans. He cites the re­quire­ment in the dec­la­ra­tion to im­me­di­ately stop a study and pro­ceed to wide­spread prod­uct avail­abil­ity when there is “con­clu­sive proof of pos­i­tive and ben­e­fi­cial re­sults,” not­ing that man­dat­ing ad­di­tional tri­als where re­search has al­ready pro­duced de­fin­i­tive find­ings would only put hu­mans at un­nec­es­sary risk.

San­ders in­tro­duced leg­is­la­tion last year that would re­quire reg­u­la­tors to ac­cept such pre­vi­ous clin­i­cal trial data, which biosim­i­lar man­u­fac­tur­ers could pur­chase from the name-brand drug­maker, as part of biosim­i­lar drug ap­pli­ca­tions.

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