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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.