Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neu­las­ta sales slip, Am­gen has yet an­oth­er biosim­i­lar to look out for: Am­neal Phar­ma­ceu­ti­cals and Kashiv Bio­sciences’ Fly­ne­tra.

Fly­ne­tra be­came the fifth ap­proved biosim­i­lar to Neu­las­ta on Fri­day, snag­ging a win in neu­trope­nia, a con­di­tion com­mon among chemother­a­py pa­tients where neu­trophils, a type of white blood cell that fights in­fec­tion, are too low.

As of last sum­mer, the list price of Neu­las­ta was more than $6,400 per dose. It’s de­signed to be tak­en in a sin­gle dose per chemother­a­py cy­cle. Am­neal de­clined to re­veal how much it in­tends to charge for Fly­ne­tra in an email to End­points News. 

“Biosim­i­lars rep­re­sent the next wave of af­ford­able med­i­cines and are close­ly aligned with our mis­sion to pro­vide high qual­i­ty, af­ford­able med­i­cines to as many pa­tients as pos­si­ble,” co-CEOs Chi­rag and Chin­tu Pa­tel said in a news re­lease.

This isn’t Am­neal’s first suc­cess­ful crack at an Am­gen on­col­o­gy drug. Ear­li­er this year, the New Jer­sey-based com­pa­ny swung an ap­proval for Releuko, a biosim­i­lar to Am­gen’s Ne­u­pogen, which is de­signed to stim­u­late the growth of white blood cells af­ter can­cer treat­ment. It al­so won an OK for Alym­sys, a copy­cat of Genen­tech’s Avastin.

All three prod­ucts are ex­pect­ed to launch in the sec­ond half of this year, Am­neal said.

Neu­las­ta, one of Am­gen’s old­est drug fran­chis­es, has strug­gled amid ris­ing pres­sure from cheap­er gener­ics. While Neu­las­ta brought in more than $4 bil­lion back in 2016, sales topped out at just $1.7 bil­lion last year, down 24% from the year be­fore that.

The first Neu­las­ta biosim­i­lar, Vit­ris’ Ful­phi­la, won ap­proval in 2018 — and the fol­low­ing year, Neu­las­ta sales fell 28% to $3.22 bil­lion. The low­est re­tail price for Ful­phi­la, ac­cord­ing to GoodRx, is around $2,400, which is a near 60% dis­count from the av­er­age re­tail price of Neu­las­ta.

Pfiz­er’s Nyvepria, Co­herus’ Udeny­ca, and San­doz’s Ziex­ten­zo are al­so ap­proved as biosim­i­lars to Neu­las­ta.

Hei­di Hunter

While the ad­vance­ment of biosim­i­lars has been slug­gish — due in part to fierce op­po­si­tion from phar­ma com­pa­nies mak­ing top-dol­lar on their orig­i­nal bi­o­log­ics — Car­di­nal Health re­searchers said ear­li­er this year that mo­men­tum is gain­ing.

“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,” Car­di­nal Health’s spe­cial­ty so­lu­tions pres­i­dent Hei­di Hunter told End­points.

The first biosim­i­lar ever ap­proved, Zarxio, al­so tar­get­ed an Am­gen drug, Ne­u­pogen. Since then, the adop­tion of biosim­i­lars start­ed slow but has ac­cel­er­at­ed more re­cent­ly.

Last year marked sev­er­al mile­stones in the biosim­i­lars space, in­clud­ing 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. Am­gen’s Am­je­vi­ta will be the first Hu­mi­ra biosim­i­lar to come to mar­ket, start­ing next Jan­u­ary.

Mean­while, the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion took is­sue last sum­mer with so-called mis­lead­ing ban­ner ads for Neu­las­ta. OPDP not­ed in an un­ti­tled let­ter that cer­tain claims and pre­sen­ta­tions in the ads “cre­ate a mis­lead­ing im­pres­sion re­gard­ing the ben­e­fit of the prod­uct.”

For ex­am­ple, Am­gen said in the ads that there is a sta­tis­ti­cal­ly sig­nif­i­cant high­er risk of febrile neu­trope­nia when Neu­las­ta is ad­min­is­tered via the pre­filled sy­ringe com­pared to its On­pro on-body in­jec­tor.

“How­ev­er, the mul­ti­ple lim­i­ta­tions of the cit­ed study pre­clude the draw­ing of such con­clu­sions re­gard­ing the com­par­a­tive risk of febrile neu­trope­nia (FN) in pa­tients tak­ing peg­fil­gras­tim de­pend­ing on de­liv­ery method,” the FDA said.

The mis­lead­ing claims could al­so have an ef­fect on biosim­i­lars, the agency warned:

The above mis­lead­ing claims and pre­sen­ta­tions are par­tic­u­lar­ly con­cern­ing from a pub­lic health per­spec­tive be­cause they could un­der­mine con­fi­dence not just in Neu­las­ta de­liv­ered via PFS but al­so in FDA-li­censed biosim­i­lar peg­fil­gras­tim prod­ucts, which are on­ly de­liv­ered via PFS.

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

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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.

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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.

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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.

Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.