US FDA Approves Low-Cost Humira BioSimilar Alternative from Amgen

us-fdaThe United States Food and Drug Administration has just approved adalimumab-atto (under the brand name Amjevita), for Amgen, Inc as a drug biosimilar to AbbVie’s adalimumab drug, Humira.  Humira was originally approved in December of 2002 for the treatment of various inflammatory diseases.  Development in this field—less expensive anti-inflammatory drugs—is considered to be a pivotal point in the US cutback of specialty drug spending, a sector of health care that has doubled—to roughly $150 billion—since 2010.  For example, Humira accounted for roughly 60 percent of AbbVie’s total revenue just last year.

Humira’s biosimilar Amjevita has been approved for the treatment of:

  • moderate-to-severe [active] rheumatoid arthritis
  • active psoriatic arthritis
  • active ankylosing spondylitis
  • moderate-to-severe [active] Crohn’s disease
  • moderate-to-severe [active] ulcerative colitis
  • moderate-to-severe plaque psoriasis

On top of this, though, Amjevita (adalimumab-atto) has also been approved to treat moderate-to-severe [active] polyarticualr juvenile idiopathic arthritis in children 4 years of age and older.

According to FDA Center for Drug Evaluation and Research director Jane Woodcock, MD, Amjevita (adalimumab-atto) is now the fourth biosimilar drug approved by the United States Food and Drug Administration. Of course, this sector of the drug industry is still emerging, as she describes: “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”

Biosimilar drugs, of course, are materials that have demonstrated their composition is remarkably similar to another drug that has been approved and do not have any meaningful differences in “safety, purity, and potency,” explains the FDA.  In addition, though, while adalimumab-atto is similar in “safety, purity, and potency” to adalimumab, it is also similar in its potential risks.  As such, Amjevita has the boxed warning cautioning its risk for serious and even fatal infections.  The box also warns that children and adolescents treated with “tumor necrosis factor blockers” like adalimumab can also experience lymphoma and other [sometimes fatal] malignancies.

Obviously, then, it is imperative that this drug be dispensed with a patient Medication Guide which describes this crucial information, much as would be expected from a prescription with Humira.

Since the approval, though, Amgen Inc has yet to announce plans for the drug’s launch date or price.

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