Pfiz­er and Alvotech look to in­ter­change­abil­i­ty to stand out in a crowd­ed Hu­mi­ra biosim­i­lar field

With sev­en adal­i­mum­ab biosim­i­lars lined up for a stag­gered launch next year, com­pa­nies are do­ing what they can now to dif­fer­en­ti­ate them­selves from the pack vy­ing for one of the world’s best-sell­ing drugs of all time.

Both Pfiz­er and Te­va-part­nered Alvotech an­nounced sep­a­rate­ly on Fri­day and Mon­day that they are seek­ing to ob­tain an in­ter­change­abil­i­ty des­ig­na­tion for their Hu­mi­ra fol­low-ons. The des­ig­na­tion, if FDA signs off, would mean that phar­ma­cists could au­to­mat­i­cal­ly sub­sti­tute the Hu­mi­ra biosim­i­lars from both com­pa­nies with­out a doc­tor’s in­put.

The first such in­ter­change­abil­i­ty des­ig­na­tion for a Hu­mi­ra biosim­i­lar was award­ed to Boehringer’s Cyl­te­zo last Oc­to­ber.

But Pfiz­er’s case for in­ter­change­abil­i­ty (a de­ci­sion from FDA is ex­pect­ed in Q4) is a lit­tle bit dif­fer­ent be­cause its ver­sion of Ab­b­Vie’s megablock­buster Hu­mi­ra, known as Abri­la­da (adal­i­mum­ab-afzb), ini­tial­ly won FDA ap­proval in Nov. 2019, where­as Alvotech has yet to win an ap­proval.

Alvotech, how­ev­er, claims to be the on­ly com­pa­ny to have both a high-con­cen­tra­tion biosim­i­lar to Hu­mi­ra and con­duct­ed a switch­ing study to sup­port in­ter­change­abil­i­ty. Pfiz­er did not re­spond to re­quest for com­ment on whether this lat­est an­nounce­ment on Abri­la­da is for the high-con­cen­tra­tion ver­sion.

The ap­pli­ca­tion for Pfiz­er was sup­port­ed by pos­i­tive topline da­ta from a study eval­u­at­ing mul­ti­ple switch­es be­tween Abri­la­da and Hu­mi­ra, both of which were ad­min­is­tered with methotrex­ate in adult pa­tients with mod­er­ate to se­vere rheuma­toid arthri­tis. The study met its pri­ma­ry goal, Pfiz­er said, by demon­strat­ing PK equiv­a­lence in pa­tients who switched mul­ti­ple times be­tween treat­ment with the two med­i­cines. The com­pa­ny an­tic­i­pates sub­mit­ting study re­sults for pre­sen­ta­tion at an up­com­ing med­ical con­gress.

But Alvotech main­tains that the high­er con­cen­tra­tion fac­tor will be key, as, in the US, more than 80% of the pre­scrip­tions are for the high-con­cen­tra­tion ver­sion.

While the tug-of-war over who has the best Hu­mi­ra biosim­i­lar in the US drags on, Eu­rope re­mains sev­er­al years ahead, as Hu­mi­ra biosim­i­lars took more than 50% of Ab­b­Vie’s mar­ket share by De­cem­ber 2020.

The first adal­i­mum­ab biosim­i­lar, Am­gen’s Am­je­vi­ta (adal­i­mum­ab-at­to), won ap­proval in Sep­tem­ber 2016 but isn’t ex­pect­ed to launch in the US un­til Jan­u­ary 2023, and isn’t ex­pect­ed to be in­ter­change­able at launch.

Am­gen man­age­ment told an in­vestor con­fer­ence in De­cem­ber that they are con­fi­dent in their abil­i­ty to re­peat the play­book from their Hu­mi­ra biosim­i­lar ex­pe­ri­ence in Eu­rope, but al­so ac­knowl­edge Ab­b­Vie’s “for­mi­da­ble re­bate dy­nam­ics as a sig­nif­i­cant hur­dle to adop­tion with many cus­tomers.”

What’s still un­clear is how these in­ter­change­abil­i­ty des­ig­na­tions will help their spon­sors nab mar­ket share for their adal­i­mum­ab biosim­i­lars, as some be­lieve the des­ig­na­tion will make the biosim­i­lars more at­trac­tive to use or pre­scribe, but price could be a fac­tor.

“While mgmt. be­lieves this dy­nam­ic is slow­ly chang­ing, we be­lieve there is a like­li­hood that AMGN may need to match some of the eco­nom­ic ben­e­fit AB­BV gives to the PBMs to get ac­cess to for­mu­la­ries,” SVB Leerink an­a­lysts wrote in De­cem­ber.

Ab­b­Vie has sig­naled that it ex­pects about 45% ero­sion in its $20+ bil­lion Hu­mi­ra fran­chise in 2023, and man­age­ment has in­di­cat­ed that in­ter­change­able biosim­i­lars will have some im­pact on pric­ing as two in­ter­change­able biosim­i­lars were baked in­to Ab­b­Vie’s guid­ance.

The US is al­so not like­ly to see some of the ma­jor land­scape shifts in Eu­rope when Hu­mi­ra biosim­i­lars there first rolled out.

A JA­MA pa­per on Den­mark’s ex­pe­ri­ence in 2020 showed a com­plete shift to adal­i­mum­ab biosim­i­lars im­me­di­ate­ly af­ter the patent ex­pi­ra­tion of Hu­mi­ra in Oct. 2018.

“The pro­por­tion of adal­i­mum­ab biosim­i­lars in­creased from 71.6% (7040 of 9829 pens) in No­vem­ber 2018 to 95.1% (8974 of 9438 pens) in De­cem­ber 2018. Costs of adal­i­mum­ab de­creased by 82.8% from Sep­tem­ber 2018 to De­cem­ber 2018,” the study found.

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

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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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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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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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.