Knock it off: Biosim­i­lars are not a 'knock­of­f' drug

I like nice Nikes. Some can get pricey. Would I’d nev­er wear a knock­off? No.


 

Ar­salan Arif, Pub­lish­er

Let’s start at square one by ask­ing: why don’t we just call biosim­i­lars gener­ics? Or bio-gener­ics?

The pub­lic doesn’t know what a biosim­i­lar is, but gener­ics are stan­dard fare: cheap­er ver­sions pricey drugs that work. Biosim­i­lars promise to bring the cost of health­care down and ac­cess to cru­cial med­i­cines up, just like gener­ics. And now, the FDA just gave a vig­or­ous en­dorse­ment to two fran­chise-bust­ing biosim­i­lars on all in­di­ca­tions as the orig­i­nal drug.  These med­i­cines look every bit as good as brand­ed Hu­mi­ra and En­brel.

But we can’t call them a gener­ic.

To put it mild­ly: they’re hard to make, and there’s a ton at stake. Vest­ed in­ter­ests de­mand an en­tire­ly sep­a­rate term for this class of drug: biosim­i­lars. And who can blame them? As­sem­bling large pro­teins re­li­ably is a lot hard­er than copy­ing small mol­e­cules.

Fur­ther, they teach us in Biotech 101 you can’t copy a bi­o­log­i­cal drug — on­ly make them high­ly sim­i­lar. And the reg­u­la­to­ry path­ways are dif­fer­ent. Bizarrely, bio­phar­mas play of­fense and de­fense at the same time, and the de­fense tends to be any-means-nec­es­sary. This strange be­hav­ior is their fidu­cia­ry du­ty. State leg­is­la­tures, PR cam­paigns, the ju­di­cia­ry, Con­gress, noth­ing is off-lim­its in or­der to pro­tect “orig­i­na­tor” mol­e­cules. The goal is to draw a dis­tinc­tion be­tween Pure Bi­o­log­ics and the copy­cats in the minds of con­sumers, ev­i­dence be damned.

So why are some big name writ­ers call­ing biosim­i­lars a knock­offin­clud­ing the ed­i­tor of this pub­li­ca­tion?

 

Knock­off is a bad word

Every time I see the word in con­nec­tion with biosim­i­lars I cringe. As pro­fes­sion­als, we shouldn’t be us­ing it, al­though I un­der­stand why many do. My goal to­day is to con­vince our ed­i­tor, John Car­roll, and oth­ers to re­con­sid­er his use of the word. Even he notes biosim­i­lars face an up­hill road to ac­cep­tance. Why would he use a word that fur­ther com­pounds the prob­lem? One that plays in­to the hands of the com­pa­nies play­ing de­fense?

But for some, knock­off is just an­oth­er word, one more tool in the biotech ver­nac­u­lar. Per­haps we shouldn’t be read­ing so much in­to this? I asked John why he us­es it. He told me:

Writ­ing about biotech can of­ten be like writ­ing about base­ball. You can’t use the same words over and over. I use knock­off as an­oth­er word for gener­ic, and be­cause it in­di­cates that de­spite all the protests to the con­trary, com­ing up with bi­o­log­ic knock­offs has proven to be a fair­ly straight­for­ward propo­si­tion.

OK, fair. Noth­ing in­sid­i­ous there. I al­so asked Jonathan Rock­off of the Wall Street Jour­nal a few months back. His re­sponse:

 

 

So it’s just a writ­ers thing?

Does any­one else think its OK?

 

Word choice mat­ters in phar­ma. A lot.

Sor­ry Ap­ple, but no in­dus­try comes close to the per­son­al con­nec­tion be­tween con­sumer and com­pa­ny than bio­phar­ma has.  Now it’s very of­ten a poor re­la­tion­ship, but there’s no get­ting around how deeply per­son­al it is.

For in­stance, we know brand­ed tablets are more ef­fec­tive at treat­ing headaches than un­brand­ed ones. Place­bo ef­fects are stronger when prod­ucts are be­lieved to be more ex­pen­sive. The sug­ges­tion that a med­i­cine was switched to gener­ic in­creas­es the num­ber of side ef­fects.

The ef­fect of an ap­par­ent change to a brand­ed or gener­ic med­ica­tion on and side ef­fects.

 

I’ve come across that study be­fore. It feels in­tu­itive.  De­spite all the do­main knowl­edge I’ve got, I’d be ly­ing to you if I said I’d be just as hap­py tak­ing knock­off ver­sions of drugs if the brand was avail­able.

 

 

Orig­i­nal bi­o­log­ics aren’t the same ei­ther

https://twit­ter.com/cath­ode­fish/sta­tus/752538169300639745

So does that mean orig­i­nal bi­o­log­ics are al­so knock­offs (or biosim­i­lars) of them­selves?

No­body agrees. These are all made-up words any­way and their prop­er use is gov­erned by con­ven­tions, not rules. And for those of us in the in­dus­try who write about these things — we ought to be aware of our role in shap­ing these con­ven­tions. There’s no need to re­fer to it as a knock­off.

 

Biosim­i­lars are com­ing on­line here in Amer­i­ca. 

Two dis­tinct multi­bil­lion dol­lar fran­chis­es had a big tar­get drawn on them in re­cent days. So this ar­gu­ment has rapid­ly moved from the the­o­ret­i­cal to the ac­tu­al stage. Bot­tom line, the soon­er we start us­ing the term biosim­i­lar, the bet­ter.

https://twit­ter.com/Arm­strong­Drew/sta­tus/752467978369769472

 


 

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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. 

Jason Kelly. Mike Blake/Reuters via Adobe

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

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.