Skyrizi Approval in Japan Crucial for AbbVie as Biosimilar Competition Looms Large on Humira

At a time when pricing and reimbursement pressure is mounting on its blockbuster RA drug Humira (adalimumab) in the US and biosimilar competition looms large in Europe, the approval of plaque psoriasis drug Skyrizi (risankizumab) by the Japanese Ministry of Health, Labour and Welfare (MHLW) is very crucial for American biopharma major AbbVie, says GlobalData, a leading data and analytics company.

According to GlobalData’s recent report Plaque Psoriasis: Global Drug Forecast and Market Analysis to 2027, Skyrizi is expected to garner sales of $28.8 million by 2027 in Japan.

Skyrizi, an interleukin-23 (IL-23) inhibitor, is indicated for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. The approval marks the first country approval of risankizumab for the treatment of plaque psoriasis.

Recently, AbbVie adopted a positive opinion for Skyrizi from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treatment of moderate-to-severe plaque psoriasis in adult patients while the drug is also undergoing regulatory review by the FDA.

AbbVie has demonstrated that Skyrizi has shown to have stronger efficacy in head-to-head trials compared to the gold standard treatment, adalimumab (Humira). Key opinion leaders interviewed by GlobalData all anticipate risankizumab to outperform in the commercial setting due to its strong Phase III clinical trial results.

Vikesh Devlia, PhD, Immunology Analyst at GlobalData, comments “AbbVie’s efforts to ensure a rapid approval of Skyrizi demonstrate a strong shift in the company’s strategy to compensate for the impact of Humira biosimilars. Skyrizi’s speedy approval in Japan will only mean that it is a matter of time before it is approved by the FDA in the US. Furthermore, positive opinions granted by the CHMP could be seen favorably by the FDA and could aid in granting approval sooner.”

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