Humira Biosimilar Approved by FDA

Humira biosimilar Amjevita has been approved by the FDA this past month. Humira, which has been around since 2002, is produced by AbbVie Inc., and is used to treat a variety of inflammatory conditions. These include RA, psoriatic arthritis, juvenile idiopathic arthritis, adult and pediatric Crohn’s disease, ulcerative colitis, uveitis, ankylosing spondylitis, chronic plaque psoriasis, and hidradenitis suppurative. The biosimilar, produced by Amgen Inc. will be used for similar conditions, and is called Amjevita (adalimumabatto).
A biologic, like Amjevita, is derived from a living organism, such as a human, animal, yeast, or other microorganism. The biologic is also classified as a biosimilar to Humira, meaning that it acts very similarly to the original. The products are not interchangeable, however, there are very few differences clinically surrounding the drug’s safety and efficacy.
The FDA approved Amjevita on the basis of clinical evidence. This evidence included data on clinical immunogenicity, data on human pharmacokinetic and pharmacodynamics profiles, drug function and structure, data from animal studies, as well as other safety and efficacy results. The boxed warnings on the medication indicate a potential risk for infection that could turn deadly. Additionally, the label warns of malignancies developing in children and adolescents who are being treated with inhibitors of Tumor Necrosis Factor (TNF), which includes products like Amjevita and other adalimumab products.
AbbVie is currently fighting the release of Amjevita, citing infringement issues on patents, however, the drug is still pushing its way through to the market. Of the new medication, Janet Woodcock, M.D., the Director of the FDA’s Center for Drug Evaluation and Research has said, “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.” Keep a lookout for more information on Amjevita in the near future!

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