Why we need to low­er U.S. reg­u­la­to­ry bar­ri­ers around biosim­i­lar ap­provals now

The FDA’s in­ter­nal re­view on Am­gen’s biosim­i­lar of Hu­mi­ra reads like a prod­uct en­dorse­ment. Post­ed on Fri­day, the agency in­sid­ers es­sen­tial­ly said: Let’s give it a quick kiss on both cheeks and ap­prove this knock­off. It’s good to go on every in­di­ca­tion Ab­b­Vie has in the U.S., which is the lynch­pin to its glob­al, $14 bil­lion fran­chise.

The le­gal war still has to play out, but the re­al les­son here is that now that the ap­pli­ca­tions are com­ing, the agency ex­perts are hav­ing no trou­ble rec­om­mend­ing a green light to these bi­o­log­ic twins. The da­ta pack­ages they’re de­liv­er­ing are de­ci­sive. And years of watch­ing law­mak­ers and reg­u­la­tors play a tug-of-war over the rules around biosim­i­lar de­vel­op­ment have come down to this:

Biosim­i­lars are a per­fect multi­na­tion­al Big Phar­ma play. They build big Phase III stud­ies for prod­ucts they un­der­stand very well. It gives them an en­trée in­to a big mar­ket with low risk, while a high bar­ri­er lim­its com­pe­ti­tion. Even­tu­al­ly, as they crowd in­to the mar­ket, they’ll push dis­counts to the jaw-drop­ping 75%-off lev­els pre­dict­ed re­cent­ly by No­var­tis’ Joe Jimenez, who ought to know.

These are all big steps. But there’s some­thing miss­ing here. Where’s the out­cry from Con­gress for speed­ing up ap­provals?

New can­cer drugs can’t come fast enough, as far as law­mak­ers are con­cerned. Many in Con­gress have said they would give Sarep­ta a hall pass on eteplirsen, on lit­tle to no ev­i­dence of ef­fi­ca­cy. But low risk, cheap­er ver­sions of block­buster drugs? They still face a con­sid­er­able chal­lenge. Why not find ways to low­er some of the reg­u­la­to­ry bar­ri­ers, which were erect­ed as a re­sult of a ve­he­ment in­dus­try lob­by­ing cam­paign?

I’m not say­ing that Con­gress should short­en bi­o­log­ics’ ex­clu­siv­i­ty pe­ri­od. That’s an im­por­tant re­ward that has paid off with a new gen­er­a­tion of bi­o­log­ics and an un­prece­dent­ed lev­el of com­pe­ti­tion in the mar­ket­place – which is what you want to see. But eas­ing reg­u­la­tions would seem to be a per­fect bi­par­ti­san po­si­tion. The rapid ap­proval of a crit­i­cal mass of com­pet­ing bi­o­log­ics would have an im­me­di­ate im­pact on multi­bil­lion-dol­lar fran­chis­es. Busi­ness­es are helped, com­pe­ti­tion is en­cour­aged and prices are low­ered faster.

There are plen­ty of vest­ed in­ter­ests which would like to keep the high bar­ri­er in place. But it’s time to catch up with Eu­rope and change the reg­u­la­to­ry game to fa­vor biosim­i­lars. In ad­di­tion, you’d need to add patent re­form to make it hard­er to pre­vent ri­vals from field­ing biosim­i­lars af­ter the prop­er pro­tec­tion pe­ri­od has come to an end.

In this elec­tion year, that would be a strate­gic con­ces­sion to pop­ulist out­rage over drug prices. It al­so just makes sense.

The time has come.


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.