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

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.

Fresh analy­sis spot­lights car­dio ben­e­fit of J&J's In­vokana in di­a­betes pa­tients with­out his­to­ry of CV dis­ease

In­vokana sales may be mut­ed, but the di­a­betes drug is set to get some love af­ter its mak­er J&J un­veiled da­ta at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing on Tues­day sug­gest­ing the med­i­cine can con­fer a car­dio­vas­cu­lar ben­e­fit in pa­tients who do not have pre­ex­ist­ing CV dis­ease.

Back in April, J&J had re­port­ed that in the late-stage CRE­DENCE study, the SGLT2 drug scored a 30% re­duc­tion in the risk of a com­pos­ite of ail­ments: a pro­gres­sion to the dou­bling of serum cre­a­ti­nine, end-stage kid­ney dis­ease and re­nal or car­dio­vas­cu­lar death. In terms of sec­ondary end­points, the drug was al­so found be heart-pro­tec­tive: low­er­ing the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure by 31%, as well as ma­jor ad­verse CV events by 20%. In March, the com­pa­ny sub­mit­ted an ap­pli­ca­tion to ex­pand In­vokana’s la­bel to re­flect its im­pact on chron­ic kid­ney dis­ease.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.