FDA (via Endpoints News)

FDA tar­gets faster re­views for biosim­i­lar sup­ple­ments, draft guid­ance says

The FDA  on Thurs­day pub­lished new draft guid­ance ex­plain­ing how it will speed its re­view of biosim­i­lar or in­ter­change­able ap­pli­ca­tion sup­ple­ments, which can be used to up­date the ini­tial biosim­i­lar ap­proval when it is for few­er than all the ref­er­ence prod­uct’s li­censed con­di­tions of use.

The 9-page draft de­tails how FDA can­not li­cense a biosim­i­lar or in­ter­change­able prod­uct for an in­di­ca­tion pro­tect­ed by or­phan-drug ex­clu­siv­i­ty or pe­di­atric ex­clu­siv­i­ty un­til the ex­pi­ra­tion of that ex­clu­siv­i­ty. Ap­pli­cants al­so may de­cide not to seek li­cen­sure of a pro­posed biosim­i­lar or pro­posed in­ter­change­able prod­uct for con­di­tions of use that are pro­tect­ed by a patent or for oth­er rea­sons.

For in­stance, when Pfiz­er’s In­flec­tra (in­flix­imab-dyyb) and Mer­ck’s Ren­flex­is (in­flix­imab-ab­da) were first ap­proved, FDA ap­proved them for all the same in­di­ca­tions as J&J’s Rem­i­cade (in­flix­imab), ex­cept pe­di­atric ul­cer­a­tive col­i­tis. This in­di­ca­tion was ex­clud­ed be­cause J&J at the time en­joyed an FDA-grant­ed pe­ri­od of or­phan ex­clu­siv­i­ty. Sim­i­lar­ly, when Am­gen won ap­proval for its Hu­mi­ra (adal­i­mum­ab) biosim­i­lar Am­je­vi­ta (adal­i­mum­ab-at­to), the com­pa­ny did not seek ap­proval for sev­er­al in­di­ca­tions be­cause of or­phan ex­clu­siv­i­ty.

But af­ter that ex­clu­siv­i­ty or patent ex­pires, an ap­pli­cant may de­cide to sub­mit a sup­ple­ment to the li­censed 351(k) bi­o­log­ics li­cense ap­pli­ca­tion (BLA) for the pre­vi­ous­ly pro­tect­ed in­di­ca­tion.

And al­though FDA com­mit­ted to re­view­ing and act­ing on orig­i­nal 351(k) BLA sup­ple­ments with clin­i­cal da­ta with­in 10 months of re­ceipt, the agency now says such sup­ple­ments will be re­viewed and act­ed up­on in a 6-month time­frame.

“As not­ed, the Bs­U­FA II Goals Let­ter de­scribes a 10-month goal date for orig­i­nal 351(k) BLA sup­ple­ments with clin­i­cal da­ta. How­ev­er, at this time, FDA be­lieves that a re­view time­frame of 6 months will gen­er­al­ly be ap­pro­pri­ate for a sup­ple­ment to a li­censed 351(k) BLA seek­ing li­cen­sure of the biosim­i­lar or in­ter­change­able prod­uct for an ad­di­tion­al con­di­tion of use that has been pre­vi­ous­ly li­censed for the ref­er­ence prod­uct, as­sum­ing the sup­ple­ment does not raise nov­el re­view is­sues,” the draft says.

If an ap­pli­cant does not want FDA to take ac­tion on a 351(k) BLA or sup­ple­ment be­fore a spec­i­fied date, the ap­pli­cant should re­quest that FDA re­frain from act­ing on the ap­pli­ca­tion, the draft adds.

To make such a re­quest, the draft says that an ap­pli­cant should in­clude the fol­low­ing lan­guage on the cov­er let­ter of their BLA or sup­ple­ment, in bold type­face and promi­nent­ly placed above the body of the cov­er let­ter:

351(k) BLA ac­tion tim­ing re­quest: [Ap­pli­cant Name] re­quests that FDA not take ac­tion on this [ap­pli­ca­tion/sup­ple­ment] be­fore [spec­i­fied date].

The draft al­so ex­plains how the pro­posed la­bel­ing for a biosim­i­lar will de­pend on whether the ap­pli­cant is seek­ing li­cen­sure for all (or few­er) of the con­di­tions of use li­censed for the ref­er­ence prod­uct. And an ap­pli­cant may sub­mit a jus­ti­fi­ca­tion as to why, in the ap­pli­cant’s view, the draft la­bel­ing meets the re­quire­ments for ap­proval, con­sid­er­ing the con­di­tions of use for which the ap­pli­cant is seek­ing li­cen­sure.

FDA al­so says that it rec­om­mends that an ap­pli­cant seek­ing li­cen­sure for a pro­posed in­ter­change­able prod­uct seek li­cen­sure for all of the ref­er­ence prod­uct’s li­censed con­di­tions of use when pos­si­ble.


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