Last year was one of the 'most event­ful in US biosim­i­lars his­to­ry,' but these an­a­lysts say 2022 should be 'a turn­ing point'

Though last year saw few­er mar­ket en­trants in the biosim­i­lar space than years past, Car­di­nal Health still called it one of the “most event­ful” in US biosim­i­lars his­to­ry, ac­knowl­edg­ing sev­er­al key ap­provals that have the po­ten­tial to make a big splash.

So­nia Os­k­ouei

“This past year, the promise of biosim­i­lars has start­ed to be­come a re­al­i­ty, as greater com­pe­ti­tion for some of the costli­est bi­o­log­ic treat­ments on the mar­ket is be­gin­ning to dri­ve mean­ing­ful cost sav­ings,” So­nia Os­k­ouei, VP of biosim­i­lars at Car­di­nal, wrote in the com­pa­ny’s re­cent­ly re­leased re­port.

Last year’s mile­stones in­clude the ap­proval of Vi­a­tris’ Sem­glee as the first in­ter­change­able biosim­i­lar, the first OK for a biosim­i­lar in oph­thal­mol­o­gy, and the first in­ter­change­abil­i­ty des­ig­na­tion for a biosim­i­lar to Ab­b­Vie’s block­buster Hu­mi­ra. Look­ing to the next few years, Car­di­nal Health says these piv­otal drugs will serve as case stud­ies on how pay­ers, phar­ma­cy ben­e­fit man­agers (PBMs) and the phar­ma in­dus­try will re­act to the bur­geon­ing field.

The slug­gish ad­vance­ment of biosim­i­lars — cheap­er treat­ments that are just as safe and ef­fec­tive as their cost­ly orig­i­nals — kicked off in 2010, when the Bi­o­log­ics Price Com­pe­ti­tion and In­no­va­tion Act es­tab­lished an ab­bre­vi­at­ed path­way to FDA ap­proval.

The first biosim­i­lar — Zarxio, a ver­sion of Am­gen’s white blood cell boost­er Ne­u­pogen — won ap­proval in 2015. Since then, 32 oth­ers have been ap­proved, 21 of which have al­ready hit the mar­ket. But that isn’t to say it’s been easy. Biosim­i­lars have been met with fierce op­po­si­tion from phar­ma com­pa­nies mak­ing top-dol­lar on their orig­i­nal bi­o­log­ics — the lat­ter suc­cess­ful­ly de­lay­ing launch­es for 10 of the 33 cur­rent­ly ap­proved biosim­i­lars through patent lit­i­ga­tion.

How­ev­er, the adop­tion of biosim­i­lars tends to ac­cel­er­ate quick­ly af­ter mar­ket in­tro­duc­tion, ac­cord­ing to Car­di­nal Health. And their use has grown sig­nif­i­cant­ly since 2015.

Mo­men­tum is “stronger than ever” in the biosim­i­lar space, Car­di­nal Health’s spe­cial­ty so­lu­tions pres­i­dent Hei­di Hunter said. Last year, Vi­a­tris’ Sem­glee be­came the first in­ter­change­able biosim­i­lar, mean­ing it can be sub­sti­tut­ed for the orig­i­nal in­sulins with­out a doc­tor’s in­put. The drug ref­er­ences San­foi’s long-act­ing in­sulin, Lan­tus.

Up­on launch­ing in No­vem­ber, Vi­a­tris said the list price would be set at about $400 for a pack­age of five 3 mL pens, which is about $20 cheap­er than the list price for the brand­ed ver­sion. The com­pa­ny al­so si­mul­ta­ne­ous­ly launched an un­brand­ed ver­sion of its in­sulin glargine prod­uct at a 65% list price dis­count, which the com­pa­ny called “the low­est WAC for any in­sulin glargine pen on the mar­ket to date.”

Chevon Rariy

Though as Chevon Rariy, VP and chair of vir­tu­al health at Can­cer Treat­ment Cen­ters of Amer­i­ca, not­ed in the re­port, “As in­sulin in­ter­change­able biosim­i­lar prod­ucts hit the mar­ket, on­ly time will tell if they de­liv­er on their promise of dri­ving costs down.”

Look­ing ahead to 2022, Hunter said in­sulin will serve as the “ul­ti­mate case study” on how man­aged care stake­hold­ers re­spond to in­ter­change­able biosim­i­lars, and how pay­ers and PBMs will de­sign plans and for­mu­la­ries.

The oph­thal­mol­o­gy space al­so saw its first biosim­i­lar ap­proval last year, with the FDA green light­ing By­ooviz, a sim­i­lar agent to Genen­tech’s Lu­cen­tis for reti­nal con­di­tions like neo­vas­cu­lar (wet) age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD). The drug is launch­ing this June — how­ev­er, some oph­thal­mol­o­gists re­main hes­i­tant on biosim­i­lars.

Of more than 100 oph­thal­mol­o­gists sur­veyed by Car­di­nal Health, on­ly 40% said they con­sid­ered them­selves “very fa­mil­iar with biosim­i­lars,” and un­der­stood how the FDA de­fines and eval­u­ates the class of med­i­cines. Al­most half of the re­spon­dents chose the op­tion, “I have lit­tle knowl­edge on the FDA ap­proval path­way for bi­o­log­ics.” And a quar­ter said they aren’t like­ly to pre­scribe a biosim­i­lar to any pa­tient.

When asked what would help them achieve a greater un­der­stand­ing of biosim­i­lars, a vast ma­jor­i­ty (82%) of oph­thal­mol­o­gists said they’d need more ed­u­ca­tion about safe­ty, ef­fi­ca­cy and per­for­mance.

Physi­cians in oth­er ar­eas ap­pear more com­fort­able with biosim­i­lars, in­clud­ing on­col­o­gists, who over­whelm­ing­ly said they’d pre­scribe a biosim­i­lar with an FDA ap­proval based on ex­trap­o­la­tion. More than 7 in 10 par­tic­i­pat­ing on­col­o­gists said they are “very” or “mod­er­ate­ly” com­fort­able with the au­to­mat­ic sub­sti­tu­tion of biosim­i­lars.

Sev­en­teen of the 21 biosim­i­lars cur­rent­ly on the mar­ket are on­col­o­gy drugs. How­ev­er, those drugs could soon face a se­ries of hur­dles, Car­di­nal notes. The On­col­o­gy Care Mod­el — a five-year project by the Cen­ters for Medicare and Med­ic­aid In­no­va­tion that has suc­cess­ful­ly dri­ven biosim­i­lar adop­tion — is set to ex­pire this year, with no suc­ces­sor in place.

Bruce Fein­berg

“The OCM will ex­pire in 2022, and with no re­place­ment VBC re­im­burse­ment mod­el yet an­nounced, on­col­o­gy prac­tices may see a gap for as long as 18 months, which could re­sult in pre­scrib­ing pat­terns re­vert­ing to pri­or brand pref­er­ences,” Bruce Fein­berg, CMO of Car­di­nal Health spe­cial­ty so­lu­tions, wrote.

On­col­o­gy biosim­i­lars may al­so face com­pe­ti­tion from sec­ond-and third-gen­er­a­tion drugs in de­vel­op­ment.

Then there’s Boehringer In­gel­heim’s Hu­mi­ra biosim­i­lar Cyl­te­zo, which was grant­ed in­ter­change­abil­i­ty sta­tus this past year. Cyl­te­zo is cur­rent­ly one of sev­en FDA-ap­proved biosim­i­lars to Hu­mi­ra that are ex­pect­ed to hit the mar­ket in 2023.

“It is no co­in­ci­dence that the num­ber one sell­ing drug in the world, Hu­mi­ra, comes with the most ex­ten­sive list of biosim­i­lar can­di­dates,” Os­k­ouei said in the re­port. “With mul­ti­ple oth­er can­di­dates in de­vel­op­ment, and var­i­ous prod­uct at­trib­ut­es as­so­ci­at­ed with each one, com­pe­ti­tion is ex­pect­ed to be fierce.”

While it’s un­clear what 2022 will hold in store for biosim­i­lar pric­ing and cov­er­age, Car­di­nal says one mes­sage is clear: Mo­men­tum in this space is ac­cel­er­at­ing. An­a­lysts say biosim­i­lars are on track to re­duce US drug ex­pen­di­ture by $133 bil­lion by 2025.

“2022 is set to be a turn­ing point in the U.S., as biosim­i­lars ex­pand in­to new ther­a­peu­tic ar­eas and sites of care, and re­im­burse­ment mod­els con­tin­ue to evolve,” Hunter said.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.