Lil­ly wins FDA ap­proval for sec­ond in­ter­change­able in­sulin biosim­i­lar

The emer­gence of in­ter­change­able biosim­i­lars since the path­way opened up has been slow. But the FDA on Thurs­day ap­proved the fourth in­ter­change­able biosim­i­lar, which is al­so the sec­ond in­ter­change­able biosim­i­lar in­sulin prod­uct.

Eli Lil­ly’s Rezvoglar (in­sulin glargine-aglr), which con­vert­ed to an in­ter­change­able af­ter an ear­li­er biosim­i­lar ap­proval in De­cem­ber 2021, fol­lows Vi­a­tris’ Sem­glee in seek­ing out a niche to com­pete with Sanofi’s block­buster Lan­tus (in­sulin glargine).

And while the FDA and biosim­i­lar ex­perts have said that in­ter­change­ables will dri­ve price com­pe­ti­tion, Vi­a­tris launched both a high- and low­er-priced ver­sion of Sem­glee to deal with the mar­ket dy­nam­ics, and Lil­ly did not re­spond to a re­quest for com­ment on the price of Rezvoglar mov­ing for­ward.

These in­ter­change­able des­ig­na­tions mean Sem­glee and Rezvoglar may be sub­sti­tut­ed at the phar­ma­cy lev­el for Lan­tus, with­out a doc­tor’s pre­scrip­tion, and as long as the state phar­ma­cy law per­mits the switch.

The FDA has al­so been more per­mis­sive of ap­prov­ing in­ter­change­able biosim­i­lars, which come with 12 months of ex­clu­siv­i­ty, with­out meet­ing all of the stip­u­la­tions that the agency ini­tial­ly laid out.

In the case of Rezvoglar, an FDA spokesper­son told End­points News that no new clin­i­cal da­ta need­ed to be sub­mit­ted to sup­port the in­ter­change­able tag. “Nei­ther a com­par­a­tive clin­i­cal im­muno­genic­i­ty study nor a switch­ing study was need­ed to sup­port li­cen­sure,” the spokesper­son said.

Cur­rent “state-of-the-art an­a­lyt­i­cal tools” used to eval­u­ate the qual­i­ty at­trib­ut­es for in­sulin can al­low for com­par­isons “thor­ough enough that a par­tic­u­lar pro­posed biosim­i­lar in­sulin prod­uct that is ‘high­ly sim­i­lar’ to its ref­er­ence prod­uct gen­er­al­ly would be ex­pect­ed, like the ref­er­ence prod­uct, to have min­i­mal or no risk of clin­i­cal im­pact from im­muno­genic­i­ty,” the FDA spokesper­son added, not­ing:

Based on the con­tents of the 351(k) BLA, in­clud­ing a com­pre­hen­sive and ro­bust an­a­lyt­i­cal as­sess­ment that com­pared the struc­tur­al and func­tion­al char­ac­ter­is­tics of Rezvoglar to Lan­tus (in­sulin glargine), hu­man phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic da­ta that com­pared sys­temic ex­po­sure and glu­cose re­sponse rates, and a clin­i­cal im­muno­genic­i­ty as­sess­ment jus­ti­fy­ing why a com­par­a­tive clin­i­cal im­muno­genic­i­ty study was not need­ed, FDA de­ter­mined that nei­ther a clin­i­cal im­muno­genic­i­ty study nor a switch­ing study were need­ed to sup­port li­cen­sure of Rezvoglar as in­ter­change­able to Lan­tus. In oth­er words, no ad­di­tion­al clin­i­cal stud­ies were need­ed to sup­port ap­prov­ing Rezvoglar as in­ter­change­able with Lan­tus be­yond those need­ed to sup­port ap­prov­ing Rezvoglar as biosim­i­lar to Lan­tus.  The in­for­ma­tion sub­mit­ted demon­strat­ed that Rezvoglar (in­sulin glargine-aglr) can be ex­pect­ed to pro­duce the same clin­i­cal re­sult as Lan­tus in any giv­en pa­tient and that the risk in terms of safe­ty or di­min­ished ef­fi­ca­cy of al­ter­nat­ing or switch­ing be­tween use of Rezvoglar (in­sulin glargine-aglr) and Lan­tus is not greater than the risk of us­ing Lan­tus with­out such al­ter­na­tion or switch.

Vi­a­tris’ Sem­glee sim­i­lar­ly won ap­proval as an in­ter­change­able to Lan­tus even though FDA al­so didn’t re­quire a clin­i­cal im­muno­genic­i­ty study com­par­ing Sem­glee to Lan­tus.

Sim­i­lar­ly, biosim­i­lar com­pa­ny Co­herus Bio­Sciences won ap­proval in Au­gust for Cimer­li (ranibizum­ab-eqrn), an in­ter­change­able biosim­i­lar to Roche’s in­jec­tion Lu­cen­tis, with­out run­ning a switch­ing study to see how pa­tients fared af­ter mov­ing from Lu­cen­tis to the in­ter­change­able. The agency said in this case it:

be­lieves that the risk of a clin­i­cal­ly im­pact­ful im­muno­genic re­sponse from sys­temic an­ti-drug an­ti­bod­ies and in­traoc­u­lar in­flam­ma­tion when al­ter­nat­ing or switch­ing be­tween Cimer­li and Lu­cen­tis is low. A switch­ing study that com­pares im­muno­genic­i­ty and phar­ma­co­ki­net­ics (PK) and/or phar­ma­co­dy­nam­ics (PD) will not be in­for­ma­tive to demon­strate that the risk in terms of safe­ty or di­min­ished ef­fi­ca­cy of al­ter­nat­ing or switch­ing be­tween Cimer­li and Lu­cen­tis is not greater than the risk of us­ing Lu­cen­tis with­out such al­ter­na­tion or switch.

Jacque­line Cor­ri­g­an-Cu­ray

The fu­ture for in­ter­change­able biosim­i­lars will like­ly hit more in­sulins and Ab­b­Vie’s block­buster Hu­mi­ra next year. In the case of Hu­mi­ra, Boehringer In­gel­heim is ready to launch its adal­i­mum­ab in­ter­change­able, and sev­er­al oth­ers may be forth­com­ing next year.

Over the next five years, the FDA’s biosim­i­lar lead­ers are push­ing for­ward with a sharp­er fo­cus on in­ter­change­ables too.

“What we’re go­ing to re­al­ly fo­cus on in Bs­U­FA III is how to de­vel­op an in­ter­change­able prod­uct,” Jacque­line Cor­ri­g­an-Cu­ray, who’s al­so lead­ing the search for a new di­rec­tor of FDA’s Of­fice of Gener­ic Drugs, ex­plained at a re­cent in­dus­try con­fer­ence.

Ed­i­tor’s note: Up­dat­ed with com­ment from the FDA.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

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