Af­ter re­port­ing pos­i­tive da­ta in non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis last month, No­var­tis’ block­buster Cosen­tyx was dealt a set­back on Fri­day.

In the 52-week EX­CEED tri­al in 800 bi­o­log­ic-naïve ac­tive pso­ri­at­ic arthri­tis pa­tients, the IL-17A drug was test­ed against Ab­b­Vie’s flag­ship Hu­mi­ra. The main goal of the study was to show Cosen­tyx was sta­tis­ti­cal­ly su­pe­ri­or us­ing re­sponse rates to ACR20, a stan­dard mea­sure that looks for a 20% re­cov­ery in the num­ber of ten­der and num­ber of swollen joints, and a 20% im­prove­ment in three oth­er cat­e­gories at week 52.

Al­though Cosen­tyx monother­a­py re­sult­ed in high­er re­sults ver­sus Hu­mi­ra, it “nar­row­ly” missed the main goal of sta­tis­ti­cal su­pe­ri­or­i­ty. De­tailed da­ta will be pre­sent­ed at a lat­er date.

Cosen­tyx — ap­proved for pso­ri­at­ic arthri­tis, plaque pso­ri­a­sis and anky­los­ing spondyli­tis — has been No­var­tis’ biggest sell­er in the first nine months of 2019, gen­er­at­ing about $2.6 bil­lion in sales over the pe­ri­od. It in­hibits a pro­tein called IL-17A from bind­ing to its re­cep­tor and was the first-ever ap­proved such ther­a­py to se­cure ap­proval, launch­ing in 2015.

Since then, ri­vals have emerged, in­clud­ing Eli Lil­ly’s IL-17A ther­a­py Taltz, and J&J’s an­ti-IL23 Trem­fya. Bausch Health’s (for­mer­ly Valeant’s) Siliq tar­gets IL-17RA and is ap­proved for plaque pso­ri­a­sis, but is cur­rent­ly be­ing eval­u­at­ed for pso­ri­at­ic arthri­tis.

For Ab­b­Vie, its TNF in­hibitor Hu­mi­ra — ap­proved for an ar­ray of au­toim­mune con­di­tions — has been the gift that keeps giv­ing. The drug — which hit a stu­pen­dous $20 bil­lion in sales last year, earn­ing it the crown of the world’s best sell­ing ther­a­py — has be­gun to see ero­sion in Eu­ro­pean sales due to biosim­i­lar com­pe­ti­tion, and a US patent cliff is loom­ing.

In Au­gust, Ab­b­Vie’s JAK in­hibitor upadac­i­tinib se­cured FDA ap­proval as part of the drug­mak­er’s post-Hu­mi­ra plans.  But the class of drugs has been blight­ed by safe­ty con­cerns — con­se­quent­ly, upadac­i­tinib’s ap­proval was ac­com­pa­nied by a black box warn­ing.  Mean­while, Ab­b­Vie has al­so planned for a post-Hu­mi­ra world with a $63 bil­lion deal to swal­low Al­ler­gan and its key­stone Botox fran­chise.

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.