FDA Advisors Recommend Approval of Adalimumab (Humira) Biosimilar

AbbVie threatens patent battle

The FDA’s Arthritis Advisory Committee has concluded that a biosimilar version of adalimumab (Humira, AbbVie) is highly similar to the original and should be approved. The panel voted unanimously (26–0) that the drug, ABP 501 (Amgen), which was studied in rheumatoid arthritis (RA) and plaque psoriasis, is similar to adalimumab in terms of safety and efficacy.

The FDA is not obligated to follow the advice of its advisory committees but typically does so. The panel’s conclusions were consistent with those of FDA scientists, who published their preliminary review of the biosimilar product on July 8.

According to a Reuters report, AbbVie is trying to block Amgen’s copy-cat drug from reaching the market, claiming that it has patents to protect adalimumab, the world’s biggest-selling drug, in the United States until at least 2022.

The FDA’s advisory committee also concluded that the study results in RA and plaque psoriasis could be extrapolated to other conditions for which adalimumab is approved, including Crohn’s disease in adults and ulcerative colitis, and should be approved for those conditions as well.

Some analysts expect the biosimilar drug to be available well before 2022 and foresee sales of adalimumab falling by as much as 18% in 2019.

Source: Reuters; July 12, 2016.