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.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.