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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”