Amgen recently filed for FDA approval of it’s first biosimilar drug, an alternative to Humira (bonus, some info was presented on APB 501 at the recent American College of Rheumatology conference that Creaky Joints wrote up).
But what could this mean for you?
We hear the terms generic, brand name, and biosimilar thrown around a lot these days, so let’s start with defining each.
The difference between brand name and generic drugs is easily known in the chronic illness world. Brand name is what you generally see on commercials – Humira, Lipitor, Cialis, etc.
According to the Center for Drug Evaluation and Research (CDER), a generic drug is:
“A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” (slide 7)
A generic version of a brand name drug can be created after patents end (20 years- slides 8 & 9) or if the creating company/person waives patent rights, as long as FDA requirements are met… like bioequivalence:
“A generic drug is considered to be bioequivalent to the brand name drug if:
The rate and extent of absorption do not show a significant difference from the listed drug, or
The extent of absorption does not show a significant difference and any difference in rate is intentional or not medically significant.” (slide 12)
It may be easy to assume that biosimilars are the same as generics right?
WRONG.
Here is a great visual from Amgen (they’re not paying me – I just love this info!):
As you can see, a biosimilar isn’t the same as the original drug. In fact, the chemistry of it can be different enough that the bonds don’t really even resemble the brand name.
So how do they even work?
Biosimilars go through a vetting process with the FDA, not unlike those that generics go through but a little more involved, proving that their version of a drug is as effective as the original brand name version. As such, there is much more analysis that goes into the biosimilar process than the original.
Amgen Biosimilars actually has a great comparison of biosimilars and generics to help define the differences between the two terms. Creaky Joints has a great breakdown as well.
Biosimilars are a great thing! This could save us money, get more drug options out there, and perhaps help someone unable to get on a certain drug due to insurance issues at least onto the biosimilar.
It’s not all golden though.
There was a good fight to get naming protocols in place and, thanks to Creaky Joints and Seth’s 50 State Network, that’s been dealt with.
The biggest issue right now is patient notification.
Thanks to Amgen, you can see where things currently stand.
A quick note – not all biosimilars will be interchangeable. The problem is, though, that the drugs that are deemed interchangeable can be substituted for your original medication even if the script is written specifically for the name-brand drug.
One of the biggest problems with that is that this can be done without the notification of the patient OR the healthcare provider.
Yeah, kind of a problem, especially as our bodies don’t always react to different medications the same no matter how similar they are. Some people aren’t able to take omeprazole (Prilosec generic), for example, as their body doesn’t process the medication the same way due to the slight differences.
For us arthritics, this could be bad news. Even if you’re stable on a medication, your insurance or your pharmacy could do this, possibly bringing someone out of medicated remission, and you wouldn’t quite be able to figure out what happened for a bit.
Would you be able to get stable again?
I certainly don’t want to find out!
Want to join Seth’s 50 State Network and help make sure that patients are notified when drugs are changed? Check it out here!