Bioregnum, Pharma

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

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

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.



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