An advisory panel of the
Federal Drug Administration (FDA) recently recommended approval of a medication manufactured
by Amgen as a feasible alternative product to Humira, a brand created by AbbVie.
The panel also cautioned that biosimilars, which are biopharmaceutical drugs designed to have active properties similar to previously licensed medicines, can be misleading in that the FDA has said they do not necessarily serve as automatic replacements.
Some stakeholders expressed concern that patients already using Humira for such conditions as arthritis, psoriasis, Crohn’s disease and related disorders may switch out to Amgen’s product purely because of cost savings, but that the FDA has not actually termed the biosimilar as interchangeable.
Ameet Sarpatwari, a Harvard Medical School doctor, stated that such fears may be overstated because biosimilars by definition carry no significant differences from brand-name drugs.
"My hunch is that 'non-medical switching' is coded language developed as part of an orchestrated PR campaign to stir up concerns over doing what is best for the patient, not the bottom line of the insurer or payer,” Sarpatwari said. “Ultimately, though, both could benefit from [biosimilars]."
Humira (adalimumab) is approved for the treatment of rheumatoid arthritis, chronic plaque psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.
Amgen is headquartered in Thousand Oaks, California.
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