Spot­light on drug pric­ing could be cat­a­lyst for change in US biosim­i­lar land­scape

While biosim­i­lar mak­ers have long es­tab­lished them­selves in Eu­rope, on­ly a few copy­cat ver­sions of bi­o­log­ics have launched in the nascent US mar­ket, which is be­gin­ning to show signs of ma­tur­ing, but is com­pli­cat­ed by a re­im­burse­ment land­scape frac­tured by mul­ti­ple play­ers. The spot­light on drug pric­ing, how­ev­er, may at long last pro­vide the cat­a­lyst for change.

Biosim­i­lars were ap­proved in the Unit­ed States amidst much fan­fare in 2015, years af­ter their in­tro­duc­tion in Eu­rope, thanks part­ly to the tac­tics em­ployed by Big Phar­ma to ever­green the patent pro­tec­tion of their prized block­buster bi­o­log­ics in the world’s biggest mar­ket for drugs.

Ab­b­Vie $AB­BV, for in­stance, has en­sured that all but one biosim­i­lar mak­er will de­lay launch­ing copy­cat ver­sions of its flag­ship Hu­mi­ra — which brought in rough­ly $12 bil­lion in US sales last year — to 2023 in the Unit­ed States. The one dis­si­dent, who is still wrestling with Ab­b­Vie in the courts, is Boehringer In­gel­heim.

Ear­li­er this week, the Ger­man drug­mak­er said it had de­cid­ed to fo­cus all its ef­fort in­to launch­ing its Hu­mi­ra biosim­i­lar Cyl­te­zo in the Unit­ed States, and would aban­don its en­tire biosim­i­lar de­vel­op­ment pro­gram else­where. Mean­while Ab­b­Vie has not been able to keep biosim­i­lar com­pe­ti­tion at bay in Eu­rope, where at least four Hu­mi­ra copy­cats have al­ready been launched, forc­ing the com­pa­ny to slash the rheuma­toid arthri­tis drug’s price by 80% in Eu­ro­pean mar­kets to re­main com­pet­i­tive.

The few copy­cats that have launched on the US mar­ket out of the 15 that have se­cured FDA ap­proval have not so far gar­nered sig­nif­i­cant mar­ket share com­pared to their Eu­ro­pean coun­ter­parts — large­ly due to pric­ing dy­nam­ics and re­im­burse­ment hur­dles. Yet with po­lit­i­cal pres­sure reach­ing full boil on drug pric­ing in the Unit­ed States, new­er en­trants may be forced to tem­per their pric­ing strat­e­gy, which could en­tice in­sur­ance cov­er­age, and help their mak­ers chip away at the mo­nop­oly of es­tab­lished brand­ed bi­o­log­ics.

On Wednes­day, Te­va $TE­VA and Cell­tri­on’s once-re­ject­ed biosim­i­lar for Roche’s non-Hodgkin’s lym­phoma drug Rit­ux­an was ap­proved by the FDA — but the two part­ners have not dis­closed their pric­ing plans for the drug, Trux­i­ma, or of­fered a launch date. Sales of Rit­ux­an, one of Roche’s ar­se­nal of can­cer block­busters, have al­ready plum­met­ed in Eu­rope thanks to biosim­i­lar com­pe­ti­tion. Te­va and Cell­tri­on are al­so gear­ing up for a US ap­proval for a Her­ceptin biosim­i­lar, which could deal a fur­ther blow to Roche’s $20 bil­lion can­cer fran­chise.

Sev­erin Schwan

But Roche is con­vinced that marked dif­fer­ence in biosim­i­lar dy­nam­ics be­tween Eu­rope and the Unit­ed States will per­sist. Last month, as part of a quar­ter­ly earn­ings con­fer­ence call, CEO Sev­erin Schwan put on a brave face: “I would put the US in a high­ly het­ero­ge­neous sys­tem and…let’s be clear we ex­pect sig­nif­i­cant en­trant of biosim­i­lars, we don’t ex­pect the ero­sion rate to be sim­i­lar to Eu­rope at this stage even with some po­ten­tial ad­di­tion­al ac­tiv­i­ties with the ad­min­is­tra­tion in the U.S. gov­ern­ment.”

But un­der com­mis­sion­er Scott Got­tlieb, the FDA seems up­beat about the fu­ture of biosim­i­lars.

“We’re ad­vanc­ing new poli­cies to make the de­vel­op­ment of biosim­i­lars more ef­fi­cient and to en­able more op­por­tu­ni­ties for biosim­i­lar man­u­fac­tur­ers to make these prod­ucts com­mer­cial­ly suc­cess­ful and com­pet­i­tive,” Got­tlieb said in a state­ment an­nounc­ing the Trux­i­ma ap­proval. “We’re see­ing more biosim­i­lar drugs gain mar­ket share as this in­dus­try ma­tures.”

In Eu­rope, how­ev­er, biosim­i­lar com­pe­ti­tion has be­gun to hurt mak­ers of brand­ed drugs in a mean­ing­ful way. Ab­b­Vie, in its re­cent quar­ter­ly earn­ings call, sug­gest­ed the pric­ing pres­sure they are fac­ing in the Eu­rope from Hu­mi­ra biosim­i­lars is greater than pre­vi­ous­ly an­tic­i­pat­ed. The com­pa­ny has now fore­cast a 26-27% ero­sion in Hu­mi­ra ex-US sales in 2019, from a pre­vi­ous es­ti­mate of 18-20%.

Vi­mal Di­van

As the land­scape for biosim­i­lars evolves at a dif­fer­ent pace in Eu­rope ver­sus the Unit­ed States, there is a mixed bag of de­vel­op­ments to keep track of, not­ed Cred­it Su­isse’s Vi­mal Di­van.

On the pos­i­tive side, the FDA has ap­proved three biosim­i­lars in re­cent weeks — Trux­i­ma, Co­herus’ Neu­las­ta biosim­i­lar Udeny­ca, and No­var­tis’ ver­sion of Hu­mi­ra, Hy­ri­moz. On the neg­a­tive side, oth­er than Boehringer’s de­ci­sion to ter­mi­nate biosim­i­lar de­vel­op­ment out­side the Unit­ed States, Mer­ck $MRK has al­so axed the de­vel­op­ment of their knock­off of Lan­tus, and No­var­tis’ San­doz unit has stopped their Rit­ux­an biosim­i­lar pro­gram in the US.

As it stands, Pfiz­er and No­var­tis are best po­si­tioned to weath­er po­ten­tial biosim­i­lar threats in the com­ing years, Di­van said, not­ing that the two drug­mak­ers are al­so de­vel­op­ing their own biosim­i­lars, which could help off­set some of that risk. Un­sur­pris­ing­ly, the two com­pa­nies that have the most to lose are Ab­b­Vie and Roche.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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