Anyone info on biosimilar as opposed to biologics?

Hello, reading up on how probably in near future due to nhs bisher cuts biosimilar medications will be prescribed instead of biologics for our kinds of illnesses, does anyone take them ot has any info on the subject?

I have an opinion if that is of any use. Biosimilars are a crap shoot. There is a common misunderstanding that Biosimilars are ā€œGenericsā€ They are not. A generic is an exact coppy of a namebrand drug. Biosimilars are a close but not the same thing. They are lower priced simply because the approval process is less rigorous, few trials. less data etc. Doesnā€™t mean they arenā€™t effective, the fact is some are even better than what they are copying.

AMGEVITA biosimilar to Humira is one such example. study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of those given Humira. almost 5% responde better with the Bosimilar In the psoriasis study, which looked at the degree of improvement after 16 weeks, there was an 81% improvement in symptom score with Amgevita compared with an 83% improvement with Humira. So better response but less effect on psoriasis (but a statistically insignificant difference. While the numbers seem similar the difference is huge. Response being the big factor here.

Something else happened thats more than a tad bit interesting (to me) Amgevita was formulated with out any citrates making it available to more folk with fewer side effects. The interesting thing is AbbVie responded by reformulating Humira to be citrate free the sting is gone if nothing else.

So the crap shoot comment? ALL biologics are a crap shoot. I wouldnā€™t be at all hesitent to use/try a biosimilar. Either they work or they donā€™t. Same with the ā€œoriginalā€ either it works or it doesnā€™t. The testing is abbreviated with biosimilars BUT one requirement for approval is they have to be at LEAST as efficous as what they are ā€œsimilarā€ too. Good luck keep us posted. I know there are several members here using biosimilars to Remicade and Enbrel with good success. Hopefully they will chime in

FWIW while not quite a biosimilar I am using a variation of Simponi formulated to be used as an IV medication (mostly as workaround to US medicare which fully covers IV biologics but not so much self injectables. I love it I mean really love it.

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Thank you very much for your interesting and prompt response. It is of great comfort and relief. Think had read something along those lines, but first hand info is more important. We are all advancing in virgin territory to some extent, not only for this disease, and have to be careful of toxic side effects of whatever is prescribed where possible. Have a nice day, regards,

Iā€™m on a biosimilar to Enbrel called Benepali. However as I was never on Enbrel only this, I canā€™t you whether thereā€™s any difference between them from my point of view.

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Thank you for your info. Am not even sure Italian Health Service will apply biosimilars to patients already on biologics, but spending review guidelines may indicate that situation. In theory there may be no problem even in that case, so great. How are you faring with your benepal? Regards,

Thamks @letizia. Initially when I started it in July I was a fast responder. Sadly I was advised to stop it for a week (itā€™s taken weekly) to get a tooth out. Then I became a slow responder. Itā€™s finally doing something useful now. But my thoughts are ā€˜is this all itā€™s going to be?ā€™ Unfortunately Iā€™m presently suffering a significant abdominal issue not yet fully diagnosed - donā€™t think itā€™s connected though to taking Benepali or indeed PsA - weā€™ll see, but maybe the awfulness of that has scewed my thoughts on Benepali somewhat, I donā€™t know.

However the NHS is switching over people to biosimilars who were on the originals as fast as they can from what I hear. If any of them donā€™t do as well, theyā€™re switching them back but obviously the more cost savings they can get the better. So Iā€™d guess other european Health Services are watching carefully. x

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Am sorry to hear about your stomach condition, of course it would let your mind off biologics. Had reduced medication effect as well after my September hip operation, maybe resulting inflammation from other conditions weaken our treatmentsā€™ response? Am trying to generally help w alternate short fasts and keto diet. Please keep us posted w developments, have a nice day,

Hi, like pootherapy i have tried Benepali, a biosimilar, but didnā€™t work for me.
Have now been on Humira for 4 weeks, no response yet. However, I had a letter from my prescribing hospital last week to say they will be changing me to the cheaper biosimilar from my next delivery. So Iā€™ll get another two Humira injections before I switch.
I really hope one of them works! I can totally see the cost benefit to the NHS of the biosimilars and therefore being able to treat more people, as long as they are as good as/better than the original. I am heartened by tntlambs stats above, thanks.
Good to hear youā€™re getting some response from Benepali, poo, hope it keeps improving and you get the abdo stuff sorted too - was it diverticulitis?

Hello you,

Well Iā€™m presently in hospital for the said ā€˜abdoā€™ issues, since Friday, thankfully a BUPA financed one through work. The issues are virulent diarrheoa for the past 6 weeks. The scans show Iā€™ve got diverticulitis but only mildly, very mildly. But my stupid body is locked into ensuring I need shares in loo rolls and keeping me resident in my bathroom. And truly making life miserable.

Thus far still no infecion although second stool sample is still cooking. Now of course Iā€™m thinking the IV antibiotics have taken over the mantle of ensuring my residency in the loo, too. Weā€™ll see.

But on the good side this hospitalā€™s cheese board is rather nice. Still think of you everytime I eat cheese. Wish me luck.

This doesnā€™t apply to biosimillars specifically, itā€™s how the FDA works in general. When a company is basing a new drug or a new medical device on one that has has already been approved the testing is much less detailed (as someone else has mentioned) and here is what I feel is the most important point:

The FDA does not do any specific fact checking or updating on the orignial item sited as the basis for the simillar product or, in the case of a device, the original device.

What does this mean? Letā€™s say someone has developed an improvement on a medication thatā€™s already on the market, letā€™s say the new version is extended release with a better half life than the original. The original is sited in the truncated paperwork and testing along with the original FDA approval. No one at the FDA checks to see if the original medication has been pulled from the market or has had unexpected side effects after it went to market. They just rubber stamp the approval because the new item is based on an old item that was approved. This is much, much more common in medical devices than actual medication, but the fact that biosmilliar are SIMILLIAR to current products and not generics of should be taken into account. And I believe very careful attention should be paid to what, exactly, itā€™s similliar to and how.

azurelle

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Oh Pooh! I mean, literally!

Itā€™s no fun, is it? Have they given steroids a bash for just a couple of days yet? Or still too worried thereā€™s a major infection to throw steroids at it? (I ask about steroids on the off-chance itā€™s due to inflammation in your gi tract).

Funny, cheese was always my go to so that I would stop losing weight when mine was playing up - glad to hear they have a respectable cheeses plate!

I really do hope they resolve it soon.

Hi poo, so sorry to hear youā€™re in hospital, though maybe theyā€™ll get to the bottom of things now (literally!).

Interestingly i just googled Benepali side effects and one precaution is that in younger people being treated with JIA it has caused inflammatory bowel disease, which can cause raging diarrhoea, abdo pain and weight loss. Iā€™m sure youā€™ve thought of this in between sitting on the loo!

Good luck truly wished xx

Oh what? Some folk will do anything for a free pre-Christmas dinner! (I seriously hope youā€™ll be out of there well before then though!)

Iā€™d be sitting there muttering ā€˜why? why?ā€™. I hope that question is answered soon and that relief is just around the corner. Iā€™m not trying to make everything sound like a toilet euphemism, itā€™s just coming out that way. Too much time spent watching Benny Hill as a kid.

Lousy luck and Iā€™m so sorry to hear this. Get well Poo!

A.laker, I had this thought too. Itā€™s not common, but happens with Enbrel as well. Iā€™ll never know if my IBD was triggered by weaning off long term steroids or going on Enbrel, as I did both at the same time.

I had had one previous episode of it years earlier though, so for me it was just a trigger, not new onset.

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Iā€™ve been in Enbrel and then onto Benepali. Both seemed to work well for me thankful;y so havenā€™t had any known issues in moving to a Biosimilar.

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Thanks for this, just what I needed to hear from someone who knows a thing or two.

Iā€™ve been told to stop Imraldi immediately due to a rash & throat tightness and it looks like Iā€™ll be starting Amgevita soon.

With no way of knowing whether the rash is definitely a reaction to something in the Imraldi injection and a tendency to throat tightness, soreness etc. anyway, Iā€™ve been wondering whether ā€˜wait & seeā€™ might have been better. But Rheumatology nurse was adamant and I do understand why and I do appreciate her proactivity.

Sounds like Iā€™ve got a good chance of getting along fine with Amgy.

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Poor you. All Imraldi is doing for me presently is making me poo for England. Not diarrhoea but seriously too much poo.

Letā€™s hope the new one works better for you.

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Maybe a change in screenname? POO may be a self-fulfilling prophesey

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Poo was always meant to be a self-fulfilling prophetcy! My screen name makes me smile. Itā€™s good to smileā€¦

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I agree. Unless that self fulfilling prophecy is actual poo in large quantities lol. Donā€™t mind my warped sense of humor

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