Let’s Talk Biosimilars
There has been several messages in 2016 with questions about biosimilars, and what the implications are/will be for UC’ers who might be interested, or prescribed these “relatively” new medications.
So, what are biosimilars…maybe we should start there.
Here is what wikipedia has to say for biosimilars:
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products, and can be manufactured when the original product’s patent expires. Reference to the innovator product is an integral component of the approval.
As many of you know by firsthand experience, myself included, western medication especially with regards to treating ulcerative colitis can lead you (and your gastroenterologist doctor) down the road to some quite hard-core medications. I for example went from 5-ASA medications and prednisone after my diagnosis, to Remicade and then Humira and then was lined up for surgery before I began changing my program to a diet based treatment for almost 7 years now. But back to the medications, and specifically medications like Remicade…they are incredibly expensive, and whether you have insurance or not, someone is paying a hefty price to the pharmaceutical companies for this type of treatment.
Not surprisingly, for a whole host of reasons, the drug industry started to develop what are now known as biosimilars, or near equivalents of specific biologic medications. This sounds like a good idea, here are some top of the head reasons for why:
- If there is compentition for a specific product, let’s take Remicade for example…maybe the price will begin to decline
- If more people are able (can afford) a specific biosimilar/innovative product equivalent…maybe more results in terms of outcomes will make it more clear as to the overall effectiveness of he medications
- With more experiences, it will be easier to understand the side effects, or adverse events that future and current patients should consider (while discussing the decision to move forward or not with your doctor/gastro)
- Maybe the ability to create, manufacture, and eventually gain marketing authorization to sell a biosimilar will speed up the process and make it more attractive to other pharma companies to develop biosimilars that are even better than the original innovative product…(we will have to wait and see)
Current Studies with regards to biosimilars for Ulcerative Colitis medications:
- Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis.
- Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study.
- Biosimilars: Rationale and current regulatory landscape.
- Current status of biosimilars in the treatment of inflammatory bowel diseases
My Questions for the UC’ers out Here…
Have You Taken or Talked about Biosimilars with Anybody?
- Are you taking a biosimilar
- Has your doctor mentioned them to you yet?
- What questions do you have about biosimilars?
- If a biosimilar was approved for lets say Remicade, would you be nervous to switch from Remicade if you were currently taking that?
- What are your thoughts on Biosimilars?
Whether you are a big medication person or not, I think it should be pretty fascinating to all of us that this whole concept of biosimilars is unfolding right before our eyes. They are approved in several countries, and are gaining steam very quickly, so if biosimilars are new to you, I can assure you that you will be hearing about them in the near future more and more.
You for sure can bring the topic up with your gastro doctors or general practice docs, maybe they will as well have some ideas for you.
Enjoy your weeks, and hoping you’re doing well,
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I started site and the eNewsletter(you can join that below) shortly after being diagnosed with ulcerative colitis in October of 2008 with severe pancolitis (when my whole colon was inflamed).
For me, it was a very rough start with severe symptoms. Getting bounced from medication to medication was not easy or too helpful. But, I did meet another UC’er, changes several parts of my diet, and of course the rest is history.
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