FDA Approves Adalimumab-atto, a Biosimilar of Humira

WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira).

The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions.

Amjevita is the fourth biosimilar to be approved by the FDA. Last month, it approved Novartis AG’s biosimilar version of Amgen’s arthritis drug, etanercept (Enbrel).

The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.

Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…

After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.

Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.

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