What is a biosimilar, exactly?

What is a biosimilar, exactly?


Remember Lipitor? There was a time when you couldn’t watch a
basketball game or a “Jeopardy!” episode without seeing an ad for Pfizer’s multibillion-dollar
cholesterol drug. “And now I’m also taking Lipitor. If you’ve been kidding yourself about high
cholesterol, stop.” But then, one day, all the Lipitor ads went
away. That’s because Lipitor, 15 years after winning
FDA approval, went generic. That means that Pfizer no longer had the exclusive
rights to sell it, and thus no longer had the incentive to spend millions of dollars
putting it on your TV screen. But here’s an ad you might have seen literally
today. “Proof of less joint pain. And clearer skin. Proof that I can fight psoriatic arthritis. With Humira.” That’s Humira, a drug that won FDA approval
more than 16 years ago, and yet here we are, still seeing TV commercials extolling its
virtues, almost every day. So why is there no generic Humira? That’s because there’s no such thing as generics
for drugs like Humira. It gets complicated, but there are such things
called biosimilars, and that’s what we’re going to talk about today. What household names like Lipitor, Cialis,
and Claritin have in common is that they’re pills, which means they’re made up of chemicals
that can be reliably and identically reproduced the very second that their patents run out. But drugs like Humira are different. They’re part of a class of medicines called
biologics. And unlike those pills we talked about, biologics
are grown from actual living organisms, not mixed together from readily available chemicals. And that’s why they can never technically
go “generic.” Humira is an antibody grown from bacteria
to mimic an actual human protein. So if you wanted to make a Humira of your
own, scientifically, you could do so, but the bacteria you use would never be identical
to the one that produced the original drug. Which is where we get to the term biosimilar:
a biologic that works pretty much exactly like the drug it’s referencing, but is not
technically interchangeable or “generic.” So why is that important? Well, because the process of manufacturing
those biologics is so complex, it involves a lot of patents. And because it involves a lot of patents,
it creates a lot of opportunity for lawsuits. So let’s get back to Lipitor and Humira. When Lipitor’s patents expired in 2011, a
generic version of the drug was on the market within literally days. Whereas for Humira, the main patent on the
drug expired back in 2016, and yet as of this very moment, there are no biosimilars of Humira
on the market in the United States. And that’s because of the word “main.” AbbVie, the inventor of Humira, has created
what lawyers call a “patent thicket.” That means patenting the manufacturing process,
patenting the liquid formulation of the drug, patenting how it’s injected, and on and on
and on. And because of that thicket, at least as things
stand right now, it doesn’t look like Humira is going to face biosimilar competition, at
least in this country, until 2023, which, of course, is seven years after the “main”
patent technically expired. All of this is very important to drug prices. It probably goes without saying, but once
a drug goes generic, the price tends to come down by an order of magnitude. And when it comes to these biologic drugs,
which can cost thousands of dollars a month, biosimilars have the potential to really save
money for the health care system. The story of Humira illustrates how these
new biologic medicines haven’t been forced to play by the same rules. Which is a long way of saying that all those
happy Humira patients you see on TV aren’t going anywhere anytime soon. “Humira can lower your ability to fight infections.”

Leave a Reply

Your email address will not be published. Required fields are marked *