Robert Hadley | Apr 7, 2017

Generic arthritis medicine shown effective in clinical trial

Sufferers of rheumatoid arthritis and a range of other inflammatory disorders may soon be able to purchase a generic version of adalimumab, the active ingredient in the popular medicine Humira.

Manufactured by Sandoz Pharmaceuticals, a division of Novartis, the generic medication passed Phase 3 clinical trials, showing the biosimilar drug was equal to the name brand option in safety and effectiveness, according to a March 6 press release.

Sandoz presented the results of the 17-week study at the annual conference of the American Academy of Dermatology in Orlando, Fla. By the penultimate week of the test, 67 percent and 65 percent, respectively, of the generic and name-brand users showed a rating of 75 or better on the Psoriasis Area and Severity Index.

Dr. Mark Levick, global head of Sandoz’s biopharma division, said offering the generic version will allow more patients to effectively treat their disorder.

"Currently, it is estimated that as few as 5 percent of eligible psoriasis patients get the biologics they need,” Levick said in the release. "We are pleased the data reinforce the potential of our biosimilar adalimumab, if approved, to be another treatment option for moderate-to-severe chronic plaque psoriasis and other inflammatory diseases.”

The announcement said next step for Sandoz is to apply for Food and Drug Administration approval, the final step before the drug can be marketed and prescribed.

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