Sen­a­tors seek changes to FDA guid­ance to speed en­try of in­sulin biosim­i­lars

As Eli Lil­ly an­nounced Mon­day that it would in­tro­duce an au­tho­rized gener­ic ver­sion of its Hu­ma­log in­sulin at half the orig­i­nal price, four sen­a­tors on both sides of the aisle are seek­ing tweaks to re­cent FDA guid­ance to speed up the mar­ket­ing of new biosim­i­lar in­sulin prod­ucts.

The guid­ance is part of FDA’s work to be­gin, start­ing in March 2020, tran­si­tion­ing ap­proved mar­ket­ing ap­pli­ca­tions for a sub­set of prod­ucts, in­clud­ing in­sulin and hu­man growth hor­mone — pre­vi­ous­ly ap­proved as drugs un­der sec­tion 505 of the FD&C Act — to be bi­o­log­ics.

But ques­tions re­main on whether this tran­si­tion pe­ri­od will briefly halt com­pa­nies from seek­ing to bring in­sulin com­pe­ti­tion to mar­ket.

Sens. Dick Durbin (D-IL), Kevin Cramer (R-ND), Tina Smith (D-MN) and Bill Cas­sidy (R-LA) wrote in a let­ter sent Fri­day to FDA Com­mis­sion­er Scott Got­tlieb that al­though this FDA guid­ance will fa­cil­i­tate the sub­mis­sion of biosim­i­lar in­sulin prod­ucts for the first time, “the cur­rent reg­u­la­to­ry frame­work still in­tro­duces per­verse in­cen­tives that could de­lay the in­tro­duc­tion of low-cost in­sulin prod­ucts in­to the mar­ket in the short-term, when they are need­ed most.”

“Our first con­cern is that ap­proved in­sulin ‘fol­low-ons’ un­der the FD&C will not tran­si­tion to biosim­i­lar li­cens­es, mean­ing they can­not be sub­sti­tut­ed for brand name ver­sions by phar­ma­cists,” they wrote.

They al­so take is­sue, as sev­er­al oth­ers have, with the fact that com­pa­nies with fol­low-on in­sulin ap­pli­ca­tions pend­ing or ten­ta­tive­ly ap­proved on 23 March 2020 will be re­ject­ed by FDA and have to be re-sub­mit­ted by the com­pa­nies.

“If FDA has the abil­i­ty to of­fer flex­i­bil­i­ty in one do­main, rec­og­niz­ing the cum­ber­some re­quire­ment to with­draw and re-sub­mit an ap­pli­ca­tion, then FDA should of­fer sim­i­lar flex­i­bil­i­ty for pend­ing and/or ten­ta­tive­ly ap­proved” in­sulin ap­pli­ca­tions, the sen­a­tors write. “No po­ten­tial ap­pli­cant who is oth­er­wise pre­pared to file to­day would sen­si­bly do so in the face of the loom­ing March 23, 2020 cut-off date—such ap­pli­cants would in­stead wait over a year un­til they would sub­mit un­der the biosim­i­lar ap­pli­ca­tion path­way.”

The sen­a­tors al­so seek ex­pla­na­tions from FDA, by 15 March, on three is­sues: “(1) the steps FDA is tak­ing the ex­pe­dite the ap­proval of in­sulin fol­low-on ap­pli­ca­tions pri­or to the March 23, 2020 dead­line, (2) how many ap­pli­ca­tions are cur­rent­ly pend­ing, and (3) whether FDA an­tic­i­pates ap­prov­ing any in­sulin fol­low-on ap­pli­ca­tions pri­or to the March 23, 2020 dead­line.”

In clos­ing, the sen­a­tors said they “re­main con­cerned the Agency’s 2018 guid­ance has flaws in the con­text of in­sulin prod­ucts that must be quick­ly reme­died.”

The let­ter comes as both the House and Sen­ate’s fo­cus on the price of in­sulin has in­ten­si­fied re­cent­ly.

Late last month, the Sen­ate Fi­nance Com­mit­tee be­gan a bi­par­ti­san in­ves­ti­ga­tion in­to in­sulin prices. That move fol­lowed sim­i­lar ques­tions from the House Com­mit­tee on En­er­gy and Com­merce in Jan­u­ary seek­ing more in­for­ma­tion on the root caus­es of the ris­ing cost of in­sulin from the three US in­sulin man­u­fac­tur­ers: Eli Lil­ly, No­vo Nordisk and Sanofi.

In ad­di­tion, Rep. Pe­ter Welch (D-VT) re­cent­ly in­tro­duced a bill to al­low for the im­por­ta­tion of in­sulin from Cana­da, and lat­er on as FDA sees fit, oth­er sim­i­lar coun­tries.

Let­ter to Got­tlieb

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. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

Martin Shkreli [via Getty]

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ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

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Hal Barron. GSK

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