Category: terminology tuesday

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!

Have you ever been reading material about or listening to an ad for a drug for your disease and wondered what ‘adverse event’ even means?

You’ve come to the right place!

This one is really simple. An adverse event is just a fancy term for when someone experiences something negative from a medication or product that you wouldn’t want to have happen. So, really, it’s a side effect without the larger number of patients affected.

An adverse event is considered serious when things like disability, hospitalization, something life-threatening, or death occurs. They also generally count birth defects if the mother was taking the drug or using the product while pregnant.

If you ever have a serious adverse event, obviously get help. That’s the first thing. Then you and/or your doctor can report the event to the FDA.

I’m sure you could also unofficially bring up difficulties during MedX (Sept 24-27) and the struggles to get your HCPs to hear you! I’ll be live tweeting the whole time so hit me up @kirstie_schultz, catch the live streams at the Medicine X website, and join in the conversations using the tag #MedX.

When I started to really do research into my disease several years ago, I came across the term ‘morbidity.’ It’s a bit of a shocking word, or at least was to me, due to how often it was associated with mortality. I thought for sure that morbidity meant something terrible.

Then I saw comorbidity and freaked out more.

Morbidity really just means the state of being ill due to disease. It can be used to describe a population (“SJIA patients have a higher rate of morbidity and mortality when compared to normal children their age”) or to one person alone (“Kirsten’s morbidity rose throughout college, finally coming to a head her senior year”).

Comorbidity is where two or more illnesses that can cause morbidity exist, like how those with rheumatic diseases often also have fibromyalgia.

Most of us know what mortality means… It is being mortal, being able to die or be killed.

In studies on many rheumatic diseases, morbidity and mortality are often listed together. This can be a way to generalize that the population with a certain disease like SJIA tend to have higher rates of death or disability from their disease or related complications.

Want to learn more medical terms? Join me on my MedX journey Sept 24-27! I’ll be live tweeting the whole time so hit me up@kirstie_schultz, catch the live streams at the Medicine X website, and join in the conversations using the tag #MedX.

Defining pain may seem slightly silly. We all have experienced it at one point or another, whether it’s acute like a sprain or chronic like JA. Definitions often cite unpleasantness due to external stimulation or tissue damage or sensory and emotional issues.

The biggest thing to know about pain is that it’s a product of the nervous system. Your nerves, some of which are better at detecting damage or are closer to areas we tend to hurt more, send messages to your brain via your spinal cord to say “HEY! THIS IS A THING AND IT ISN’T FUN!”

That message is a little altered on the way up to the brain, so pain that occurs often or is quite small isn’t as big of a deal. Sometimes it may not even be communicated at all.

Your brain sends endorphins and other pain-killing chemicals out to help lessen the pain. Depending on what you injured, your inflammatory buddies will head to the injured area and cause a little swelling and/or patrol for invaders and germs.

Chronic pain is rough. My fibromyalgia is considered a “lifelong central nervous system disorder.” My brain doesn’t process some signals correctly – some of that could be the spine’s fault – and I wind up feeling widespread pain from things that are not painful… like clothing rubbing against my skin.

We all know pain is so much more than these signals, but I think this is something we have to keep in mind. We can be so angry at ourselves, at our bodies for not working. Oftentimes these signals get mixed up due to trauma or other illnesses or any number of things. Let’s be patient with ourselves and our bodies, as we might be with a sick child.