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FDA Approves New Drug for Rheumatoid Arthritis

People with rheumatoid or juvenile arthritis will soon have another safe and effective alternative to expensive biologic medications.

On September 29, the FDA announced the approval of a new drug for rhuematoid arthritis called Tofidence (tocilizumab-bavi), made by Biogen, as a biosimilar alternative to U.S.-licensed Actemra (tocilizumab).

Like Actemra, Tofidence is an interleukin-6 (IL-6) receptor antagonist that helps suppress the immune system. The drug is administered through intravenous injection and is approved to treat rheumatoid arthritis in adults. It's also approved to treat polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children ages two and older.

Moreover, Tofidence is the first biosimilar medication FDA-approved to treat systemic juvenile idiopathic arthritis.

Rheumatoid arthritis (RA) is an autoimmune and inflammatory condition that typically impacts the joints of the hands, wrists, feet, and knees, causing swelling and sometimes deformity of the joints. Treatment of RA includes antirheumatic medications and drugs that suppress the immune system, like Actemra.

Polyarticular Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis are similar to RA. However, polyarticular disease primarily involves multiple joints, while systemic arthritis can also cause fever, lymph node swelling, rash, and spleen or liver enlargement. Treatment for both disease types includes antirheumatic drugs and biologic agents.

According to the FDA, the approval came after a comprehensive review of scientific evidence, which demonstrated the new biosimilar drug had the same safety profile and efficacy as Actemra. Side effects associated with Tofidence include upper respiratory tract infections, common cold, headache, hypertension, increased risk of elevated liver enzymes, and injection site reactions.

What are biosimilar drugs?

A biosimilar is a biological drug product that is highly similar to biologics and made from the same living sources, such as yeast or bacteria. Because biologics are expensive to make, biosimilars provide a more affordable option for some people.

While a doctor must prescribe a biosimilar medication to replace a biologic drug, some biosimilars are interchangeable, meaning they have met additional requirements, which allows them to be substituted for a biologic by a pharmacist without consulting the prescribing physician.

Recently, the FDA approved Yuflyma (adalimumab-aaty), an alternative to Humira (adalimumab), to treat arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis.

In August, the agency also approved a biosimilar called Tyruko (natalizumab-sztn) for treating multiple sclerosis (MS).\

Biogen has not released an availability timeline for Tofidence. So, while it's exciting that there is a new drug for rheumatoid arthritis, it's unclear when it will be available to patients.


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