Biosimilars for Rheumatoid Arthritis: 5 Facts | Rheumatoid Arthritis Warrior

Biosimilars for Rheumatoid Arthritis: 5 Facts

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New Biosimilars for Rheumatoid Arthritis

Biosimilars for Rheumatoid ArthritisOne of the hottest topics in rheumatology today is biosimilars to for rheumatoid arthritis (RA) and other immune mediated diseases. Dozens of biosimilar medicines are in various stages of development and several are already in use in Europe and Asia. Let’s look at five key questions patients are asking.

1) Are Biosimilars for Rheumatoid Arthritis the same as generics?

No. Generics are copies of brand-name drugs with the same active ingredient. According to the FDA, generics are bioequivalent, but the term biosimilar was coined to describe something else: “Biosimilars are highly similar to the reference product they were compared to, but have allowable differences because they are made from living organisms.”

2) Why are Biosimilars for Rheumatoid Arthritis not generics?

Biologics are made of large protein molecules that are derived from single cell lines. That’s actually the reason these medicines are given as injections and IV infusions, in case you ever wondered. The large molecules would be broken up by the digestive system if they were swallowed.

Biosimilars are created using a separate line of cells than the original biologic. They are carefully created so as to be highly similar to the originator. Biosimilars are expected to work similarly by the same mechanisms (such as TNF inhibition) as the reference products (biologics).

Separate cell lines: “Follow-on manufacturers do not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance, although they do have access to the commercialized innovator product.”

3) How are biosimilars tested and approved?

The biosimilar approval process includes demonstrating that the biosimilar is highly similar to the originator. There should be no “clinically meaningful differences” in terms of “safety, purity, and potency.” For biosimilars for rheumatoid arthritis treatment, clinical studies are done to demonstrate similarity in pharmacokinetics (how a drug effects the body), pharmacodynamics (mechanism of action of a drug), and immunogenicity (reactivity to the product).

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4) Are Biosimilars for Rheumatoid Arthritis already FDA approved?

In 2016, the FDA has approved three biosimilars for rheumatoid arthritis treatment:

  • Biosimilar to Remicade (infliximab): Inflectra
  • Biosimilar to Humira (adalimumab): Amjevita
  • Biosimilar to Enbrel (etanercept): Erelzi

They are not in use at this time, but their launch is soon expected in the US.

5) Are Biosimilars for Rheumatoid Arthritis cheaper?

As patents expire for originator biologics, biosimilars for rheumatoid arthritis have become available in several countries. Experts are estimating cost savings with biosimilars in the U.S. to be about 15% over originator biologics, but some say it could be as much as 35%.

A new biologic drug can take up to a decade and a billion dollars to develop, with extensive clinical trials. The biosimilar process is much shorter so it is less expensive to develop.

WHAT DO YOU THINK ABOUT BIOSIMILARS TO RHEUMATOID ARTHRITIS?

IF YOU RESPOND WELL TO YOUR CURRENT TREATMENT, WOULD YOU SWITCH TO A BIOSIMILAR?

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Kelly O'Neill Young

Kelly O'Neill (formerly Kelly Young) has worked over 10 years as an advocate helping patients to be better informed and have a greater voice in their healthcare. She is the author of the best-selling book Rheumatoid Arthritis Unmasked: 10 Dangers of Rheumatoid Disease. Kelly received national acknowledgement with the 2011 WebMD Health Hero award. She is the president of the Rheumatoid Patient Foundation. Through her writing and speaking, she builds a more accurate awareness of rheumatoid disease (RD) aka rheumatoid arthritis (RA) geared toward the public and medical community; creates ways to empower patients to advocate for improved diagnosis and treatment; and brings recognition and visibility to the RA patient journey. In addition to RA Warrior, she writes periodically for newsletters, magazines, and websites. There are over 60,000 connections of her highly interactive Facebook page. You can also connect with Kelly by on Twitter or YouTube, or LinkedIn. She created the hashtag: #rheum. Kelly is a mother of five, longtime home-schooler, NASA enthusiast, and NFL fan. She has lived over thirteen years with unrelenting RD. See also https:/rawarrior.com/kelly-young-press/

8 thoughts on “Biosimilars for Rheumatoid Arthritis: 5 Facts

  • November 23, 2016 at 7:45 pm
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    Yes, I would definitely switch, I am guessing at some point most of us will because of insurance. Now wanting to switch and being made it switch that may be two different things.

    Reply
  • November 24, 2016 at 12:23 am
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    I live in Canada and have been on Inflectra the biosimilar to Remicade for one year. I had been on Cimzia injections successfully for 4years til Cimzia began losing its efffect and I was declining. The studies and succcess of Inflectra were explained to me in detail by my Doctor and I decided to try it. So far, the results have been successful for me and my symptoms are now back under control. I always research new drugs before introducing them to my body and I was surprised at the length of time Inflectra has successfullly been in use in Europe. I am lucky our health care covers all drugs especially when taking Cimzia as it was approx $3500.00 per month and therefore because the biosimilars are very very much less expensive, the good old drug companies would fight biosimillars as a competitor. Sadly, the patients are not seen as sufffering humans as in the drug industry, we are dollar signs. I hope you do the research and try Inflectra if offered when you need change

    Reply
  • November 25, 2016 at 8:36 am
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    Hi there I am starting on Cimzia today was wondering how long it takes to work and if you had any side effects. Thank you very much.

    Reply
  • November 25, 2016 at 11:02 am
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    For the most part We won’t have a choice- the insurance companies make that call.

    Reply
  • November 25, 2016 at 5:56 pm
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    I agree with Laura.
    It doesn’t matter two hoots what you or I think.
    It will all be controlled by the goverment(s) and
    the insurance companies. Unfortunately this is another
    disinsentive for drug companies to continue to develop
    new biologics which is what we really need done as
    one after another biologic loses its effectiveness for us.
    Thank you for explaining “biosimilars”. It is a very helpful article.

    Reply
  • December 26, 2016 at 8:37 pm
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    I noticed “relief” within 8 weeks of taking Cimzia. Swelling decreased in my hands and very little morning stiffness. Had to make the switch from Rituxan which was not slowing the progression. Good luck!

    Reply
  • January 17, 2017 at 2:59 am
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    I live in Germany and switched to Benepali, the biosimilar of Enbrel. Good news: I had less skin reaction at the injection point where Enbrel caused itching and reddness, while its biosimilar caused no skin reaction. The conservational fluid might be different (which can be an asset in itself!). Bad News: I had a pretty strong flare while on the biosimilar and now go back to Enbrel to find out if my RA is better with Enbrel (or if both have lost their efficacy). Price difference – yes, there is, but much less than what I would have expected.

    Reply
  • March 1, 2018 at 11:53 pm
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    I live in Canada and I am about to start “Brenzys” (etanercept) a biosimilar to Enbrel has anyone had any experience with this drug to share? Thankyou

    Reply

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