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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Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

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Merck Research Laboratories CMO Roy Baynes

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