On January 31, 2023, Amgen’s AMJEVITA™ was made available to the U.S. public for the first time since being approved by the U.S. Food and Drug Administration (FDA), in 2016. [1]
AMJEVITA™ is a biosimilar to Humira® and is approved to treat seven inflammatory diseases including psoriatic arthritis in adults and moderate-to-severe chronic plaque psoriasis in adults. It is a citrate-free formulation and is available in a prefilled syringe and autoinjector, depending on indication and dosing. [1]
The FDA defines a biosimilar as a biological medication that is highly similar to an already approved biologic medicine. This may be referred to as “the original biologic” or “reference product.” These medicines are expected to have the same safety and effectiveness as the reference product. [2]
AMJEVITA™ is the first of seven biosimilars to Humira® expected to be released this year.
“We are always happy to see more treatment options available to the more than 8 million people in the U.S. living with psoriatic disease,” said Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation. “We are about to see many more biosimilars coming to the market, and this will have impacts for those with the disease as well as those who treat and care for them. NPF will continue to keep the community informed.”
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Many Voices, One Mission: Nehal N. Mehta
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Public Health and Psoriatic Disease
