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.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.