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.

Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.