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.

Rit­ux­an is one of Roche’s top-sell­ing med­i­cines, it gen­er­at­ed about $6.9 bil­lion in glob­al sales last year.

In the Unit­ed States, Cell­tri­on and Te­va’s $TE­VA Rit­ux­an biosim­i­lar, Trux­i­ma, was ap­proved last No­vem­ber by the FDA. The month pri­or, No­var­tis threw in the tow­el on get­ting its copy­cat  US ap­proval — af­ter the health reg­u­la­tor de­mand­ed ex­tra in­for­ma­tion, which skewed its time­line to the fin­ish line and en­abled its ri­vals to leapfrog it. This Ju­ly, Pfiz­er’s $PFE Rit­ux­an knock­off, Rux­ience, se­cured its FDA ap­proval.

In re­cent years, Roche has been feel­ing the heat — and bat­ting away — biosim­i­lar ri­vals eat­ing in­to rev­enues for its big Rit­ux­an, Her­ceptin and Avastin fran­chis­es.

In Eu­rope, where Rit­ux­an is brand­ed as MabThera, sales de­clined by 47% in 2018 as Cell­tri­on and No­var­tis’s knock­offs took a bite out of its mar­ket share.

But in the Unit­ed States, the mag­ni­tude of dis­counts of­fered by biosim­i­lar mak­ers dwarf the cuts seen in Eu­rope, lead­ing some crit­ics to con­clude that the US biosim­i­lar mar­ket is bro­ken.

“Even to­day there are bare­ly a dozen biosim­i­lars on the U.S. mar­ket and no com­peti­tors on the hori­zon for dozens of bi­o­log­ic drugs. The bar­ri­ers to en­try are so high that even the hun­dreds of mil­lions in sales these un­con­test­ed prod­ucts gen­er­ate isn’t enough to at­tract even one com­peti­tor,” in­flu­en­tial re­searcher Pe­ter Bach, Di­rec­tor of the Drug Pric­ing Lab at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, wrote in an opin­ion piece pub­lished in the Wall Street Jour­nal on Wednes­day, along with co-au­thor Mark Trusheim, who serves as strate­gic di­rec­tor of MIT’s New Drug De­vel­op­ment Par­a­digms.

Bach and Trusheim al­so pre­scribed an an­ti­dote: gov­ern­ment price reg­u­la­tion that gives a man­u­fac­tur­er a ‘fair price’ af­ter the bi­o­log­ic’s pe­ri­od of ex­clu­siv­i­ty ends.

“Most is­sues in drug pric­ing are con­tentious. End­ing mo­nop­oly pric­ing af­ter a com­pa­ny has been re­ward­ed for in­no­va­tion isn’t. Pur­su­ing biosim­i­lars might seem like a so­lu­tion, but this ap­proach is draw­ing pa­tients away from stud­ies of new­er ther­a­pies even as it fails to con­trol costs. Price reg­u­la­tion may be a tough sell in some quar­ters, but it’s the best way to keep the promise of Amer­i­ca’s ex­tra­or­di­nary phar­ma­ceu­ti­cal in­dus­try alive,” they con­clud­ed.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.