Pfiz­er gets biosim­i­lar ap­proved for Hu­mi­ra, set­ting up com­pe­ti­tion — in 2023

In the sto­ry law­mak­ers and drug pric­ing re­form ad­vo­cates have told about the drug in­dus­try, there are per­haps few greater vil­lains than Hu­mi­ra and its mak­er Ab­b­Vie.

Be­tween 2012 and 2018, Ab­b­Vie upped the drug’s an­nu­al af­ter-re­bates cost from $19,000 to $38,000 in the US, with stick­er prices now over $60,000 per year — in­creas­es that led to ac­cu­sa­tions of price goug­ing, most re­cent­ly from De­mo­c­ra­t­ic pres­i­den­tial fron­trun­ner Eliz­a­beth War­ren.

“Hu­mi­ra is used by mil­lions of pa­tients around the world to treat dis­eases like arthri­tis, pso­ri­a­sis, and Crohn’s dis­ease,” War­ren tweet­ed Sat­ur­day as part of a thread on drug prices. “But its man­u­fac­tur­er, Ab­b­Vie, dou­bled its price—and used bla­tant­ly an­ti-com­pet­i­tive be­hav­ior to pre­vent a com­peti­tor from en­ter­ing the mar­ket.”

But mas­sive drug pric­ing bill or not, that re­al­i­ty will change in 2023 when sev­er­al biosim­i­lars are set to come to mar­ket. An­oth­er one just of­fi­cial­ly joined the list as Pfiz­er earned the FDA nod for its biosim­i­lar, ABRI­LA­DA.

Along with sev­er­al oth­er com­pa­nies, Pfiz­er was sued by Ab­b­Vie as the old Amer­i­can phar­ma de­vel­oped their ri­val drug — a not un­com­mon move in the biosim­i­lar world. Pfiz­er set­tled last year. Like Am­gen, My­lan, Sam­sung Bioepis, San­doz, Fre­se­nius Kabi, and Mo­men­ta all did, they agreed to roll out their biosim­i­lar in 2023.

At the time Boehringer In­gel­heim was the last hold­out, telling The Cen­ter for Biosim­i­lars “we are com­mit­ted to mak­ing it avail­able to US pa­tients as soon as pos­si­ble, and cer­tain­ly be­fore 2023.” They signed an agree­ment in May to re­lease their drug, Cyl­te­zo, in 2023.

Pfiz­er billed the news as an op­por­tu­ni­ty to help pa­tients in the long list of in­di­ca­tions that have made Hu­mi­ra a block­buster: rheuma­toid arthri­tis, ju­ve­nile id­io­path­ic arthri­tis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis, adult Crohn’s dis­ease, ul­cer­a­tive col­i­tis and plaque pso­ri­a­sis. The FDA tout­ed the move as the 25th ever biosim­i­lar ap­proval and the 9th this year.

The wide in­di­ca­tion has led to huge rev­enues for Ab­b­vie — $3.89 bil­lion in Q3 2019 alone — and im­proved qual­i­ty of life for many pa­tients, but the high prices have led to sto­ries of pa­tients stag­ger­ing dos­es to man­age the cost.

“Dur­ing the hol­i­days, I was con­tem­plat­ing what am I’m go­ing to do,” one 51-year-old woman with col­i­tis and Chron’s dis­ease told The New York Times last year. “I was think­ing should I just go on a liq­uid di­et, be­cause I can’t af­ford this.”

Com­pe­ti­tion should send the prices down when the biosim­i­lars roll­out. Eight are to be re­leased that year un­der set­tle­ments with Ab­b­Vie, be­gin­ning with Am­gen’s Am­je­vi­ta on Jan­u­ary 31st. Not all have been FDA ap­proved yet.

Pfiz­er will be the last to join the par­ty, with their roll­out date sched­uled for No­vem­ber 20, 2023. They have yet to gain EMA ap­proval but can mar­ket the drug in Eu­rope the mo­ment they pass that hur­dle.

Ab­b­Vie, though, is not yet out of the woods. Short­ly af­ter Boehringer set­tled the last of the in­tel­lec­tu­al prop­er­ty rights cas­es, a class ac­tion suit was lodged al­leg­ing Ab­b­Vie used its “patent thick­et” to cre­ate an il­le­gal mo­nop­oly and that Ab­b­Vie col­lud­ed with the biosim­i­lar com­peti­tors to di­vide the mar­ket.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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