Amgen’s Neulasta good points one other biosimilar competitor as gross sales slip – Endpoints Information

Neu­las­ta, one among Am­gen’s outdated­est drug fran­chis­es, has an­oth­er biosim­i­lar to con­have a tendency with.

Ger­man phar­ma Fre­se­nius Kabi an­nounced on Tues­day that the FDA has ap­proved its peg­fil­gras­tim biosim­i­lar, to be mar­ket­ed as Stimufend. The drug will add to a develop­ing ar­se­nal of biosim­i­lars used to deal with neu­trope­nia, a con­di­tion com­mon amongst chemother­a­py pa­tients the place neu­trophils, a kind of white blood cell, are too low.

Stimufend is specif­i­cal­ly in­di­cat­ed to be used in “pa­tients with non-myeloid ma­lig­nan­cies re­ceiv­ing myelo­sup­pres­sive an­ti-can­cer medicine as­so­ci­at­ed with a clin­i­cal­ly sig­nif­i­cant in­ci­dence of febrile neu­trope­nia,” Fre­se­nius stated in a state­ment. It’s al­so the com­pa­ny’s first FDA-ap­proved biosim­i­lar.

The transfer comes just some months af­ter Kashiv Bio­sciences received an ap­proval for its Neu­las­ta biosim­i­lar Fyl­ne­tra. The Am­gen block­buster has wres­tled with biosim­i­lar com­pe­ti­tion because the first one, Vi­a­tris’ Ful­phi­la, received ap­proval in 2018.

The fol­low­ing yr, Neu­las­ta gross sales fell 28% to $3.22 bil­lion. Pfiz­er’s Nyvepria, Co­herus’ Udeny­ca, and San­doz’s Ziex­ten­zo have al­so en­tered the mar­ket since then, ship­ing gross sales on a down­ward spi­ral. The drug earned Am­gen simply $1.7 bil­lion final yr, down 24% from the yr be­fore that.

This previous quar­ter, Am­gen’s Neu­las­ta gross sales topped out at $310 mil­lion, down 36% from Q2 2021.

As of final sum­mer, the record worth of Neu­las­ta was greater than $6,400 per dose. It re­mains un­clear what Fre­se­nius will cost for its ver­sion. The com­pa­ny was not im­me­di­ate­ly avail­ready for an in­ter­view.

Fre­se­nius will launch Stimufend in a pre­crammed sy­ringe ear­ly subsequent yr, ac­wire­ing to a information re­lease, and can sub­se­quent­ly search ap­proval for an on-body in­jec­tor ver­sion.

Am­gen obtained in trou­ble with the FDA’s Of­fice of Pre­scrip­tion Drug Professional­mo­tion final sum­mer over so-called mis­lead­ing ban­ner advertisements, during which the com­pa­ny claimed there’s a sta­tis­ti­cal­ly sig­nif­i­cant excessive­er threat of febrile neu­trope­nia when Neu­las­ta is advert­min­is­tered through the pre­crammed sy­ringe com­pared to its On­professional on-body in­jec­tor.

“The above mis­lead­ing claims and pre­sen­ta­tions are par­tic­u­lar­ly con­cern­ing from a pub­lic well being per­spec­tive be­trigger they might un­der­mine con­fi­dence not simply in Neu­las­ta de­liv­ered through PFS however al­so in FDA-li­censed biosim­i­lar peg­fil­gras­tim prod­ucts, that are on­ly de­liv­ered through PFS,” the FDA stated.

Nyvepria, Udeny­ca and Ziex­ten­zo are al­so advert­min­is­tered through pre­crammed sy­ringe, ac­wire­ing to pre­scrib­ing in­for­ma­tion.