Yo,
Happy Friday, I hope y’all had a great week. I didn’t even realize it, but many of you also had a short week this week, I on the other hand did not.
Alright, time for a quiz. Can you tell the difference between the real Steve Harvey, and the doppelganger?
How about the difference between the real and fake Nike?
Saving the hardest for last, how about these two biologics? (the picture kinda spoils it)
If the answer to that third question was “no”, then join the club. I would say a majority of people, including regulators, are in the same boat when it comes to biosimilars.
Which isn’t ideal.
What’s a biosimilar?
It’s essentially a knock off brand, or doppelganger, but for biologic drugs. It’s a drug that varies in only one or two places, structurally, but behaves exactly the same as the original.
Humira is a popular example of a biosimilar drug.
These generic, biosimilar drugs are used to treat diseases like irritable bowel syndrome, Crohn’s disease, arthritis, and even more recently have been an area of interest for cancer treatments.
How did it come to be?
Well, it actually makes a lot of sense, basically, when a company creates a drug, they patent the design and structure of it so that nobody else can copy it. This could lead to monopolies and price hikes (think Martin Shkreli AKA Pharma Bro).
They call these patent blockades, which prevent competitors from figuring out the underlying drug structure.
But… patents expire. And when the company’s patent does expire it opens the market back up for competition of similar drugs (this is becoming more and more popular).
Overall, people say it’s a good thing. It increases access to these medical treatments, decreases their cost, and can improve individual experiences with drugs.
But there’s a catch
While the biosimilar market is still small compared to the overall drug market, as the number of expiring patents increase so do the number of biosimilars that are popping up.
Why is this so attractive for businesses? Well, they are guaranteed to make money (proven case study), are easier to make (just copy the one from the expired patent), and go through an abbreviated regulatory approval.
All of this is making it really hard for the FDA (and global regulatory bodies) to contain, which can end up being pretty dangerous.
Think of it like a game of telephone. If each person changes just one thing, the word or phrase comes out completely different than when it started. Which is exactly what we’re seeing here. It’s a game of proximity and scapegoating.
One company may request approval saying “Here’s Drug B. We only changed one thing from Drug A, which was already approved”. Then the next company will say “Here’s Drug C. We only changed one thing from Drug B, which was already approved.” So on and so forth.
So, while it may only be one inactive hydrogen here, or a carbon there, these changes can become exponentially different from the reference molecule.
Which could lead to an adverse event taking place that’s very difficult to investigate and pinpoint.
Tansky Toyota Sawmill
There’s no better place to go than Tansky Toyota. Car dealers can be slimy sometimes, but not Tansky, they gave a detailed run down of the car and its features, as well as a full tank of gas when I left. Go check them out, ask for Malik Patel, and tell them Matt sent ya. #ad
Anyways
Anyways, I’d keep an eye peeled for more news to come out about biosimilars, as we’re just on the cusp of adoption.
I think that as technology continues to penetrate medicine and health care becomes more personalized, the concept of biosimilars will become more relevant. Not only that, but there are some marque drug patents that will be expiring in the upcoming years.
Who knows if that will be more of a good thing or bad thing?
Let’s have ourselves a weekend!
from, matt
