Amjevita Is FDA-Approved as Biosimilar to Humira

Concerned patient discussing biosimilars with doctor.
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Amjevita (adalimumab-atto), the biosimilar to Humira (adalimumab), has been approved by the FDA for rheumatoid arthritis and various inflammatory diseases. Amjevita became the fourth biosimilar to be approved by the FDA. The biosimilars, with their FDA approval date, are:

  • Zarxio (filgrastim-sndz) - March 6, 2015
  • Inflectra (infliximab-dyyb) - April 5, 2016​
  • Erelzi (etanercept-szzs) - August 30, 2016
  • Amjevita (adalimumab-atto) - September 23, 2016

    Zarxio, unlike the others, is not indicated for rheumatic diseases, but rather it is a leukocyte growth factor. Inflectra is the biosimilar to Remicade (infliximab). Erelzi is the biosimilar to Enbrel (etanercept). Enbrel, Remicade, and Humira are biologic drugs, classified as TNF blockers.

    Indications for Amjevita

    Amjevita is indicated for the treatment of:

    • Rheumatoid Arthritis - To reduce signs and symptoms, inhibit progression of structural damage, and improve physical function in adults with moderately to severely active rheumatoid arthritis.
    • Juvenile Idiopathic Arthritis (JIA) - To reduce the signs and symptoms of moderately to severely active polyarticular JIA in children 4 years of age or older.
    • Psoriatic Arthritis - To reduce signs and symptoms, inhibit progression of structural damage, and improve physical function in adults with active psoriatic arthritis.
    • Ankylosing Spondylitis - To reduce signs and symptoms in adults with active ankylosing spondylitis.
    • Adult Crohn's Disease - To reduce signs and symptoms; to induce and maintain clinical remission in adults with moderately to severely active Crohn's disease who had an inadequate response to conventional treatment, or lost their response to Remicade, or simply could not tolerate Remicade.
    • Ulcerative Colitis - To induce and maintain clinical remission in adults with moderately or severely active ulcerative colitis who had an inadequate response to immunosuppressants. 
    • Plaque Psoriasis - For adults with moderate to severe chronic plaque psoriasis who are suitable candidates for systemic therapy or phototherapy; also, when other systemic therapies are deemed less appropriate.

    Recommended Dosage and Administration

    Amjevita is administered by subcutaneous injection. It is available as a 40 mg/0.8 mL dose in a single-use prefilled SureClick autoinjector, as a 40 mg/0.8 mL dose in a single-use prefilled glass syringe, and 20 mg/0.4 mL in a single-use prefilled glass syringe.

    The recommended dose of Amjevita for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 40 mg every other week. If you have rheumatoid arthritis and do not take methotrexate, a more frequent dose of 40 mg every week may be considered.

    For children who weigh between 33 pounds and 65 pounds, the recommended dose of Amjevita is 20 mg. every other week. The dose for children who weigh 66 pounds or more is 40 mg. every other week.

    For Crohn's disease and ulcerative colitis, on Day 1 of treatment with Amjevita, the dose is 160 mg. (note: it may be divided into 80 mg. over two consecutive days; on Day 15, the dose is 80 mg.; and on Day 29, you begin a maintenance dose of 40 mg.

    every other week. For people with plaque psoriasis, the starting dose is 80 mg. and then a week following the starting dose, the maintenance dose is 40 mg. every other week.

    Side Effects, Adverse Reactions, and Contraindications

    Common adverse reactions associated with Amjevita include infections (such as sinusitis or upper respiratory infections), injection site reactions, headache, and rash. There are no contraindications listed in the prescribing information for Amjevita.

    Warnings and Precautions

    Amjevita comes with a Black Box Warning, the most serious warning issued by the FDA.

    The black box warning is for serious infections and for malignancy.

    More specifically, Amjevita is linked to an increased risk of serious infection which could lead to hospitalization or death, including TB (tuberculosis), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections caused by opportunistic pathogens. The warning also advises discontinuation of Amjevita if serious infection or sepsis develops during treatment. A test for latent TB is recommended prior to starting treatment with Amjevita. Also, those treated with Amjevita should be monitored for active TB, even if their latent TB test is negative.

    Regarding the malignancy warning, there have been reports of lymphoma and other malignancies (some of which were fatal) in children and adolescents treated with TNF blockers. Also, there have been post-marketing reports of a rare type of T-cell lymphoma, referred to as HSTCL (hepatosplenic T-cell lymphoma), in adolescents and young adults with inflammatory bowel diseases treated with TNF blockers.

    More warnings were offered in the prescribing information:

    • You should not start Amjevita during an active infection.
    • Amjevita should be stopped if an infection becomes serious.
    • Anti-fungal therapy should be considered for people who develop systemic illness while treated with Amjevita and live or travel to regions where fungal infections are endemic.
    • Allergic reactions or anaphylaxis can occur with Amjevita.
    • Hepatitis B reactivation can occur while treated with Amjevita. HBV carriers should be monitored.
    • New onset or worsening of a demyelinating disease may occur with Amjevita.
    • Blood abnormalities may occur, including cytopenias (low number of blood cells) and pancytopenia (low number of red blood cells, white blood cells, and platelets).
    • New onset or worsening heart failure may occur while treated with Amjevita.
    • Lupus-like syndrome may develop while treated with Amjevita, requiring discontinuation.

    Drug Interactions

    There is an increased risk of serious infections with a combination of TNF blockers and Kineret (anakinra) or Orencia (abatacept). Therefore, Amjevita should not be used with anakinra or abatacept. Also, live vaccines should be avoided with Amjevita use.

    The Bottom Line

    A biosimilar receives approval based on evidence that supports that the drug is "highly similar" to a previously approved biologic drug, referred to as the reference drug. Approval purports that there is no clinically meaningful difference between the biosimilar and its reference drug.

    That said, there has been confusion and a swirl of questions that surrounded the concept of biosimilars, even before the first one was approved. Can there be 100 percent certainty that a biosimilar and its reference drug are equivalent? For prescribing purposes, is the biosimilar interchangeable with its reference drug? Will insurance companies force the use of biosimilars due to reduced cost?

    These are very big questions and they remain as questions. While a biosimilar could logically be prescribed for a newly-diagnosed patient, is it wise to expect a patient who is doing well on a biologic to switch to its biosimilar?

    At the end of 2016, there was a soft launch of Inflectra. Erelzi will not launch before 2018 as it is tied up in legal battles with Amgen. The true interchangeability of biosimilars and their reference drugs has yet to be established in a way that leaves patients and doctors feeling fully confident. Perhaps in time, this will change. In the meantime, discuss with your doctor to see which option is best for you.

    Sources:

    Amjevita. Prescribing Information. Amgen. Revised 9/2016.

    Palmer, Eric.  Sandoz head: Enbrel biosimilar Erelzi won't launch before 2018, delayed by legal battle. FiercePharma. January 25, 2017.

    Shaw, Gina. Biosimilar Infliximab Takes Cautious Steps Into Market. Specialty Pharmacy Continuum. January 23, 2017.

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