FDA Approves Biologic Drug to Treat Several Forms of Arthritis, Ankylosing Spondylitis and Plaque Psoriasis

FDA Approves Biologic Drug to Treat Several Forms of Arthritis, Ankylosing Spondylitis and Plaque Psoriasis

By Staff

People who suffer from Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Plaque Psoriasis just got some good news:  A new drug called Erelzi just received FDA approval to help manage and treat these disorders.

Erelzi (etanercept-szzs) is administered by injection and is now approved for the treatment of the following conditions:

  • moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
  • active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
  • active ankylosing spondylitis (an arthritis that affects the spine); and
  • chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

Erelzi (etanercept-szzs) is “biosimilar” to Enbrel (etanercept), which as FDA approved in 1998.  Both are biologic products derived from a living organism.  A biosimilar is a biological product that gains FDA approval based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

“We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system” said Carol Lynch, global head biopharmaceuticals, Sandoz – the maker of Erelzi.

“Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible.”

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Authored by: Staff

There are 7 comments for this article
  1. S Barlow at 6:28 am

    My Sister went from Humira to Enbrel now medicaid won’t cover it! Back to prednisone again. Ridiculous. Ankylosing Spondylitis is a debilitating monster. Maybe she can try this one….after much research first.

  2. Sandra at 8:00 am

    All these new drugs flooding market. The side effects are bad. If what you have doesn’t hel kill you the new drugs will more than likely end your life. They have a pill for everything. Many of the drugs come out shortly after that they are are in court for killing people. While in court they still seek the drug.when they have to pay money out for injury and death it’s nothing for them . They have so much money all of it is worth it for them. Please drugs should be on market for 20 years to be safe for people
    They just worry me.
    Sandra

  3. Bethany at 5:49 pm

    What studies were done to see if it is safe to take with other medications? I have so many issues and take more meds than I want to. I’m stuck and afraid of what these meds are doing to the inside of my body. New meds always worry me until they are tested with other meds or have been used enough by a variety of people. We are still human guinea pigs even though the FDA approves new meds.

  4. Linda Myers at 1:49 pm

    Biologics are not simply anti inflammatory. These drugs are very dangerous and can have deadly side effects. I would use these with extreme caution. Do your research before just blindly taking this type of medication. Although they can be beneficial for some, others may become very I’ll.

  5. Dave at 8:37 am

    New and improved anti inflammatories i cant get excited about that for it reflects more of the same innovation gap in pharmaceutical companies who conflates their profit motive with the good of people in pain.
    It reflects an excessive attachment to dated treatment methods and beliefs. It is tragic how incapable drug companies have become when it comes to creating optimal treatments. Bit i guess if they profit off such suboptimazation they really dont care.

  6. Leigh Peltier at 6:07 am

    I had to change biologics a week ago. After 8 years, Enbrel stopped working. I am grateful that it worked as long as it did and my doctor was correct when he said there was so much in the development stage. I feel very fortunate.

  7. Suz at 4:42 am

    How soon will this be available for patients on Medicaid? As it’s new, I worry that it’s cost will make it unavailable to those of us on state funded insurance.