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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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