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.

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.

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.

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.

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.”