A Penn­syl­va­nia fed­er­al judge on Wednes­day ce­ment­ed a $25 mil­lion set­tle­ment in a class ac­tion suit al­leg­ing John­son & John­son blocked biosim­i­lar com­pe­ti­tion to its im­muno­sup­pres­sive drug Rem­i­cade.

First ap­proved in 1998 for Crohn’s dis­ease, Rem­i­cade (a TNF in­hibitor bi­o­log­ic al­so known as in­flix­imab) has since been cleared in a slate of oth­er im­mune-me­di­at­ed con­di­tions, in­clud­ing ul­cer­a­tive col­i­tis, pso­ri­at­ic arthri­tis and rheuma­toid arthri­tis. How­ev­er, the year­ly cost for some pa­tients reach­es $26,000, ac­cord­ing to a com­plaint up­dat­ed in 2018.

De­spite the emer­gence of mul­ti­ple biosim­i­lars in the US — in­clud­ing Pfiz­er and Cell­tri­on’s In­flec­tra, and Mer­ck and Sam­sung Bioepis’ Ren­flex­is, now com­mer­cial­ized in part­ner­ship with Organon af­ter its spin­out — plain­tiffs ar­gued that J&J used its mo­nop­oly pow­er to sup­press com­pe­ti­tion and “forced health in­sur­ance com­pa­nies and health­care providers to en­ter in­to ex­clu­sion­ary agree­ments that ef­fec­tive­ly blocked com­pe­ti­tion for Rem­i­cade, thus caus­ing Plain­tiffs and mem­bers of the Class­es (as de­fined be­low) to over­pay on their in­flix­imab pur­chas­es.”

“These acts, each an­ti­com­pet­i­tive on their own, were mag­ni­fied when used in con­cert and all served to main­tain J&J’s stran­gle­hold on the mar­ket, main­tain its grasp on the near­ly $5 bil­lion an­nu­al mar­ket for the med­ica­tion, and shut out would-be com­peti­tors whose en­trance in­to the mar­ket would nat­u­ral­ly cause prices for the im­por­tant drug to de­cline,” a com­plaint reads.

J&J set­tled a sep­a­rate case with Pfiz­er back in 2021, which ar­gued that J&J’s “ex­clu­sion­ary plan has been re­mark­ably ef­fec­tive at sti­fling com­pe­ti­tion.” At the time, in­flix­imab biosim­i­lars con­trolled just 25% of the US mar­ket, ac­cord­ing to an in­vestor note from then-Bern­stein biotech an­a­lyst Ron­ny Gal.

While J&J de­nies wrong­do­ing in the lat­est class ac­tion case, Judge Karen Marston fi­nal­ized a $25 mil­lion set­tle­ment Wednes­day dis­miss­ing the case with prej­u­dice. The class in­cludes “per­sons and en­ti­ties in the Unit­ed States and its ter­ri­to­ries who in­di­rect­ly pur­chased, paid and/or pro­vid­ed re­im­burse­ment for some or all of the pur­chase price of De­fen­dants’ in­flix­imab from April 5, 2016 through Feb­ru­ary 28, 2022,” Marston con­clud­ed.

In ap­prov­ing the set­tle­ment, Marston al­so over­ruled the ob­jec­tions of one pa­tient who ar­gued that the set­tle­ment fig­ure was “un­rea­son­ably low.” She award­ed the class coun­sel $7 mil­lion in at­tor­ney’s fees, and near­ly $2.3 mil­lion in “out-of-pock­et ex­pens­es in­curred in the pros­e­cu­tion of this ac­tion.” Two groups, the Na­tion­al Em­ploy­ees Health Plan and the Lo­cal 295 Em­ploy­er Group Wel­fare Fund, re­ceived $15,000 and $15,600, re­spec­tive­ly, as class rep­re­sen­ta­tive ser­vice awards.

Rem­i­cade brought in $2.3 bil­lion in world­wide sales last year, down rough­ly 26% from the year pri­or, ac­cord­ing to J&J’s lat­est earn­ings re­port.

“Janssen has long been sup­port­ive of a ro­bust, com­pet­i­tive en­vi­ron­ment for bi­o­log­ics, in­clud­ing biosim­i­lars. This set­tle­ment re­solves all of the pri­vate lit­i­ga­tion on this mat­ter,” Janssen said in a state­ment via email.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to in­clude com­ment from Janssen, and to clar­i­fy that Organon is now Sam­sung’s com­mer­cial part­ner for Ren­flex­is, fol­low­ing its spin­out from Mer­ck.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.