US biosim­i­lar launch­es about to turn a cor­ner

The US biosim­i­lar in­dus­try has lin­gered in the shad­ow of the Eu­ro­pean mar­ket since the US path­way for ap­provals was ini­ti­at­ed in 2009.

Ten years lat­er (or less than five years since the first FDA ap­proval of a biosim­i­lar), and just 42% (11 out of 26) of FDA-ap­proved biosim­i­lars have launched. But in the next three months (see chart be­low), a clutch of new biosim­i­lars will hit the mar­ket, in­clud­ing new ones in on­col­o­gy, hint­ing at a wave of up­take.

For in­stance, Pfiz­er is ex­pect­ed to launch three biosim­i­lars soon: one for Avastin (be­va­cizum­ab) lat­er this month, one for Rit­ux­an (rit­ux­imab) next month, and one in Feb­ru­ary for Her­ceptin (trastuzum­ab). Two oth­er trastuzum­ab biosim­i­lars may al­so launch soon, which would mean more than 60% of biosim­i­lars ap­proved in the US will have launched by ear­ly next year.

The ris­ing num­ber of launch­es, com­bined with an in­creas­ing amount of quick up­take, may put biosim­i­lar foes on their heels.

For in­stance, Neu­las­ta (peg­fil­gras­tim) biosim­i­lars have found re­cent suc­cess, with Co­herus’ Udeny­ca (peg­fil­gras­tim-cbqv) and My­lan and Bio­con’s Ful­phi­la (peg­fil­gras­tim-jmdb) cap­tur­ing 25% mar­ket share in just over a year, ac­cord­ing to a re­port re­leased last week from Bern­stein.

Sim­i­lar­ly, a sign of rapid up­take can be seen with Am­gen’s Mvasi (be­va­cizum­ab-awwb), which has cap­tured 10% of the Avastin mar­ket in just four months.

“Biosim­i­lars are grow­ing their mar­ket share and lead­ing to mean­ing­ful price ero­sion over time; with the more re­cent biosim­i­lar launch­es show­ing a lot of suc­cess – re­flect­ing per­haps the grow­ing mar­ket so­phis­ti­ca­tion of the biosim­i­lar com­pa­nies,” for­mer FDA Com­mis­sion­er Scott Got­tlieb, re­fer­ring to the Bern­stein re­port, not­ed re­cent­ly.

And in the fu­ture, Hu­mi­ra (adal­i­mum­ab) and En­brel (etan­er­cept) biosim­i­lars (sev­en ap­proved, ze­ro launched in the US) may look more like out­liers in a larg­er pool of ap­provals and sub­se­quent launch­es. By con­trast, in the EU, Hu­mi­ra biosim­i­lars have al­ready cap­tured 35% of the mul­ti-bil­lion-dol­lar mar­ket in one year, and biosim­i­lars have cap­tured 50% of the En­brel mar­ket in about three years, ac­cord­ing to Bern­stein.

The US Rem­i­cade (in­flix­imab) biosim­i­lar mar­ket is al­so an eye­sore (Bern­stein refers to it as “es­sen­tial­ly a failed mar­ket”) as the two biosim­i­lar en­trants have on­ly amassed 12% mar­ket share in more than two years. Am­gen’s in­flix­imab biosim­i­lar was re­cent­ly ap­proved last week and may hit the mar­ket soon. And John­son & John­son said the Fed­er­al Trade Com­mis­sion has launched an in­ves­ti­ga­tion in­to its con­tract­ing prac­tices for Rem­i­cade, al­though sim­i­lar in­ves­ti­ga­tions in Cana­da and the UK yield­ed lit­tle.

“We should ban an­ti-com­pet­i­tive re­bat­ing” in mar­kets where biosim­i­lars en­tered, Got­tlieb added.

Biosim­i­lars (in or­der by FDA ap­proval date) Launched in the US?
Yes, Sept. 2015
Yes, late 2016
No, launch date un­known
(Adal­i­mum­ab -at­to)
No, com­ing on 31 Jan­u­ary 2023
Yes, Ju­ly 2017
No, com­ing on 1 Ju­ly 2023
Yes, launched in Ju­ly 2019
Yes, launched 2 De­cem­ber 2019
Not plan­ning to launch
(epo­et­in al­fa-ep­bx)
Yes, No­vem­ber 2018
Yes, Ju­ly 2018
Yes, 1 Oc­to­ber 2018
No, com­ing on 30 Sep­tem­ber 2023
Yes, No­vem­ber 2019
Yes, 3 Jan­u­ary 2019
No, un­known
No, un­known
No, launch­ing on 15 Feb­ru­ary 2020
No, un­known
Yes, launched in Ju­ly 2019
No, launch­ing on 31 De­cem­ber 2019
No, launch­ing af­ter 30 June 2023
No, launch­ing Jan­u­ary 2020
Abri­la­da (adal­i­mum­ab-afzb) No, ex­pects to launch in 2023
No, launch­ing be­fore 31 De­cem­ber 2019
Av­so­la (in­flix­imab-axxq) No, un­known

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Zachary Brennan

managing editor, RAPS

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