Rheumatoid Arthritis Support Group
Rheumatoid arthritis is a chronic, inflammatory, multisystem, autoimmune disorder. It is a disabling and painful condition which can lead to substantial loss of mobility due to pain and joint destruction. The disease is also systemic in that it often also affects many extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and...
I think I've brought this up once before, but thought I'd mention it again to see if anyone else has heard about these from their RA docs.
My doc mentioned to me that Biosimilars are in the pipeline and will really bring down the cost of biologicals.
I just looked on Wiki and found this on the topic (EMA is the equivalent to the U.S. FDA):
"In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, FDA approved Zarxio, the first biosimilar product approved in the United States.
Based on the preceding information on that page https://en.wikipedia.org/wiki/Biosimilar, I'm more than a little scared they are going to start moving us over to these. It appears there are a lot of concerns about how they are made and what is used when making them.
My doc mentioned to me that Biosimilars are in the pipeline and will really bring down the cost of biologicals.
I just looked on Wiki and found this on the topic (EMA is the equivalent to the U.S. FDA):
"In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, FDA approved Zarxio, the first biosimilar product approved in the United States.
Based on the preceding information on that page https://en.wikipedia.org/wiki/Biosimilar, I'm more than a little scared they are going to start moving us over to these. It appears there are a lot of concerns about how they are made and what is used when making them.
Xeljanz a new biologic is a short chained molecule and may be different - they may be able to make it close enough to the original that it will work.
They hadn't been around long...I finally tried Humira. It didn't bring me the complete absence of RA symptoms I was looking for and I got 2 sinus infections in a short period of time (ordinarily I am healthy and catch nothing) so I kicked it to the curb.
it all goes to function. if you can handle the side affects and you can not get out of bed or are going to lose your job your house and your bank account and your biologic gives you your life back then so be it. everything is a risk even long term predisone or mtx and every person has a different function level with this disease
depot
And for us older folks (I have five years to do), the choices are already limited for people on Medicare. I am told that you can't get injectables if you are on Medicare - you have to go in for infusions. How stupid is that? I am not looking forward to the lack of options, scared about fewer options going forward, and plan to work as long as possible so I have good medical insurance.
thinksRAs, I wouldn't expect a "complete absence of RA symptoms" ever, regardless of what drugs, how many drugs, or even any remissions you may have. It's a nice thought though, isn't it? :)
Maybe some new miracle drug will pop up soon, so we can all get off of biologics, biosimilars or not.
As they won't be identical to the originals, there's hope that someone who couldn't tolerate the brand-name drug may do just fine with the biosimilar. (The opposite, of course, is equally true.) A person who did well on Enbrel for several years then lost that lovin' feeling may get it back from a similar but not identical drug.
I have seen a price estimate of +/- $600/month for the biosimilar Enbrel. If there is an option at that price, the drug companies are going to have to re-evaluate their pricing structure for all the biologics or the insurance companies will take a line from Nancy Reagan and Just Say No.
I wouldn't want to try one until it had been on the market for at least a couple years. I am one of those who's options are getting slim so I guess I have to be in favour of more choice as long as that is what happens... More choice not forced into cheaper drugs.
The Canadian medical system is infamous for only covering the "generic" cheaper options... However I doubt that will be the case with RA meds at least not until the biosimilars are truly field tested... The Canadian System is always cautious first, cheap second.
http://jointhealth.org/programs-jhmonthly-view.cfm?id=104&locale=en-CA