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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

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In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

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Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

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The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

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Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).