Ulcerative Colitis Tips


Ulcerative Colitis Tips PLUS iHaveUC Newsletter




Ulcerative Colitis BioSimilar Medications

Let’s Talk Biosimilars

Hi UC’ers,

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:

  1. If there is compentition for a specific product, let’s take Remicade for example…maybe the price will begin to decline
  2. 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
  3. 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)
  4. 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:

  1. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis.
  2. Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study.
  3. Biosimilars: Rationale and current regulatory landscape.
  4. 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?

  1. Are you taking a biosimilar
  2. Has your doctor mentioned them to you yet?
  3. What questions do you have about biosimilars?
  4. If a biosimilar was approved for lets say Remicade, would you be nervous to switch from Remicade if you were currently taking that?
  5. 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,

 

Adam Scheuer

my ebooks

 

 






biosimilars

4 Responses to Ulcerative Colitis BioSimilar Medications

  1. Paul S
    Paul S April 26, 2016 at 2:12 pm #

    Adam,

    I have not tried biosimilars, but it’s an interesting conversation for me to watch as I am on Imuran and fighting a 7 month flare and my gastro is suggesting that the Imuran is becoming ineffective and that I should move to Remicade. Having battled UC for about 17 years and been able to achieve remission after every flare, I am still determined that I can achieve remission again through diet and the Imuran and I still have a goal to get off the Imuran completely in the not too distant future. I recently started to see a nutritionist and he has added some prebiotics, suggested some diet change and added b-12 to my daily dose of folic acid. I am already seeing promising results in less than a week and feel that I am getting close to achieving remission without having to turn to Remicade.

    I also want to thank those that shared comments on Remicade on this website as they were very helpful, and a bit disturbing as to side effects that people have encountered. It affirms to me that we each are different and we each have to advocate for ourselves and be well armed with information.

    Thanks and be well.

  2. Kathy April 26, 2016 at 8:59 pm #

    I was on Ramicade for a little over a year. I am considered medication resistant thus far. No remission so after levels of Ramicade drawn it was found not to be working and I was on the high end of normal for Ramicade.

    I have 2 drugs left to try..I just started Humira 4 weeks ago..which is one of the 2. I had someone say that Ramicade and Humira were same type of drug why would it work. Well no, they are not the same. Ramicade is mouse protein and Humira is human protein.

    I also had surgery for rectovaginal fistula. .a fistulotomy if you will. With a seton suture placed. So far normal to hard stools until 2 days ago. Now today.. blood. So bummed.

    New synthetic meds …I’m sure I’ll here about it next month. I plan to say no. I’m at the point where I don’t want meds anymore.

    New studies on foods are coming out.. actually it’s old news never talked about. We need to eat like our ancestors did. Im tired of being a lab ray for science!

  3. Robert M April 27, 2016 at 11:56 am #

    2015 article about protective patent to expire 2020, regarding biosimilars and other info. I hope this link http://fortune.com/2015/02/06/biosimilars-what-are-they/
    to article to help shed info of same thing you mention.
    Sounds promising.

  4. DebraK April 29, 2016 at 7:28 am #

    Is a biosimilar basically a generic version? If so, I wonder if the same guidelines apply–that the generic only has to have 85% of what the name brand active ingredients include? When Entocort was available in generic, I ended up with it, and it does not seem to work as effectively as the name brand, despite being made by the same company. My pharmacist said that generics only have to include 85% of the active ingredients of the name brand does.

Leave a Reply