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.

“While FDA has pub­lished sev­er­al guid­ance doc­u­ments re­lat­ed to biosim­i­lars, in­dus­try con­tin­ues to strug­gle with the lack of clar­i­ty re­gard­ing the Agency’s pol­i­cy on cer­tain as­pects of in­ter­change­abil­i­ty as well as reg­u­la­to­ry ex­pec­ta­tions for cer­tain post-ap­proval changes for biosim­i­lar or in­ter­change­able prod­ucts,” An­drea Maresca wrote on be­half of the Biosim­i­lars Fo­rum.

The Biosim­i­lars Fo­rum not­ed that FDA has specif­i­cal­ly ex­clud­ed in­ter­change­able bi­o­log­ics from its biosim­i­lar guid­ance doc­u­ments. “We ap­pre­ci­ate that these ex­clu­sions may have been nec­es­sary at that time be­cause the ini­tial core in­ter­change­abil­i­ty guid­ance had not yet been is­sued. How­ev­er, it is now an ap­pro­pri­ate time to fill in these gaps,” Maresca added.

Ar­lene Wol­ny, head of US reg­u­la­to­ry af­fairs at San­doz Bio­Phar­ma, echoed the need for more in­ter­change­abil­i­ty in­for­ma­tion from FDA to re­duce de­vel­op­ment risks for in­dus­try. The com­pa­ny rec­om­mend­ed that the agency de­vel­op in­ter­change­able guid­ance fo­cused on pro­mo­tion and ad­ver­tis­ing, la­bel­ing, prod­uct pre­sen­ta­tion, and cat­e­gories of post-ap­proval process changes.

The Arthri­tis Foun­da­tion al­so point­ed to in­ter­change­abil­i­ty as an area where FDA could be do­ing more pa­tient ed­u­ca­tion. “Clear­ing up lin­ger­ing points of con­fu­sion can help in­crease con­fi­dence in biosim­i­lars, and in par­tic­u­lar biosim­i­lars that are not deemed in­ter­change­able,” wrote An­na Hyde, a vice pres­i­dent at the Arthri­tis Foun­da­tion.

PhRMA and the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cine’s (AAM’s) Biosim­i­lars Coun­cil al­so both urged FDA to pro­vide more in­for­ma­tion about how the agency will as­sess in­ter­change­able biosim­i­lar prod­ucts. “While we have not yet seen an in­ter­change­able prod­uct li­censed un­der Bs­U­FA II, we will very like­ly see one dur­ing the five years en­com­passed by Bs­U­FA III,” Cory Wohlbach, of Te­va Phar­ma­ceu­ti­cals, wrote on be­half of AAM’s Biosim­i­lars Coun­cil. “For com­pa­nies seek­ing in­ter­change­abil­i­ty ap­proval for their biosim­i­lars, clear guid­ance to in­dus­try on re­main­ing is­sues will sig­nif­i­cant­ly fa­cil­i­tate de­vel­op­ment and reg­u­la­to­ry re­view, lead­ing to in­creased pa­tient ac­cess to the valu­able ther­a­pies.”

Oth­er com­ments

Ear­ly meet­ings, re­vised time­lines, and an­ti-com­pet­i­tive prac­tices were some of the oth­er is­sues raised in com­ments about Bs­U­FA III.

PhRMA called on FDA to es­tab­lish re­view time­lines for safe­ty la­bel­ing up­dates so that man­u­fac­tur­ers of biosim­i­lar and in­ter­change­able prod­ucts would have time­ly ac­cess to up­dat­ed in­for­ma­tion re­lat­ed to the ref­er­ence prod­uct.

Mean­while, Bio­con is ask­ing FDA to con­sid­er mov­ing from a fixed re­view time­line to an adap­tive time­line, which would con­sid­er the agency’s re­view bur­den when set­ting the time­lines. For in­stance, a prod­uct that does not re­quire com­par­a­tive clin­i­cal tri­als has a low­er re­view bur­den than a prod­uct that needs a full com­par­a­tive tri­al of safe­ty and im­muno­genic­i­ty, wrote Sun­dar Ra­manan, Bio­con’s vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs.

Bio­con al­so sug­gest­ed a short­er re­view time­line as an in­cen­tive for de­vel­op­ing biosim­i­lars in new ar­eas. “To spur fur­ther com­pe­ti­tion for mol­e­cules with lim­it­ed or no biosim­i­lars, the agency should con­sid­er a low­er re­view time­line for the first biosim­i­lar ap­pli­ca­tion, much akin to the ac­cel­er­at­ed re­view process for drugs with break­through ther­a­py des­ig­na­tion un­der Pre­scrip­tion Drug User Fee Act (PDU­FA),” Ra­manan wrote.

Some com­menters called on FDA to cre­ate more op­por­tu­ni­ties for spon­sors to in­ter­act with the agency ear­li­er in the de­vel­op­ment process. AAM’s Biosim­i­lars Coun­cil rec­om­mend­ed an ad­di­tion­al meet­ing type that would not re­quire ini­tial an­a­lyt­i­cal da­ta. This meet­ing would help to get FDA in­put on clin­i­cal end­points and study de­sign.

The Biosim­i­lars Fo­rum echoed the im­por­tance of ear­ly-stage and pre-de­vel­op­ment meet­ings, as well as the need to cre­ate a mech­a­nism for in­dus­try to ob­tain clar­i­fi­ca­tion from FDA about ad­vice or com­ments giv­en dur­ing FDA-spon­sor meet­ings.

A 10-mem­ber coali­tion of pub­lic in­ter­est and con­sumer groups, and unions, al­so weighed in on how to re­vise Bs­U­FA. The coali­tion fo­cused its com­ments on how FDA could get biosim­i­lar prod­ucts to the mar­ket faster. Its cor­re­spon­dence al­so rec­om­mend­ed that the agency co­or­di­nate with the Fed­er­al Trade Com­mis­sion (FTC) to iden­ti­fy an­ti-com­pet­i­tive busi­ness prac­tices by orig­i­nal bi­o­log­ic spon­sors, such as re­bate walls that keep new­ly ap­proved biosim­i­lars from gain­ing for­mu­la­ry ac­cess.

The coali­tion al­so called on FDA to hold a joint pub­lic work­shop with FTC and the Cen­ters for Medicare and Med­ic­aid Ser­vices to in­crease un­der­stand­ing of how re­bate walls con­tribute to biosim­i­lars be­ing blocked from drug for­mu­la­ries. “It is im­per­a­tive that FDA, FTC, and CMS en­gage the pa­tient and provider com­mu­ni­ty in these work­shops giv­en that they are most di­rect­ly im­pact­ed by the harms of the re­bate wall,” the coali­tion wrote.


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. 

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