Amgen’s Humira (adalimumab) biosimilar ABP 501 has cleared a key hurdle on its route to approval by showing comparable efficacy in a late-stage trial in patients with psoriasis.
According to Phase III data, patients given Amgen’s drug experienced a similar improvement in their disease - as measured by the Psoriasis Area and Severity Index (PASI) - to those taking AbbVie’s Humira after 16 weeks’ treatment.
Specific details were not released, but the drugmaker did note that ABP 501 also showed comparable safety and immunogenicity to Humira, and that the study is the first of two Phase III programmes that will underpin global regulatory submissions of its drug.
Humira is approved across a number of indications and rakes in a whopping $10.66 billion a year for AbbVie, making it a very attractive biosimilar target. But this also means that ABP 501 could face stiff competition from others contending for market share, including Sandoz’ Humira biosimilar, which went into Phase III testing in December last year.
Psoriasis affects around 3% of the world's population and there remains significant unmet need, as up to 30% of patients with severe forms of the condition are untreated. Because the disease requires life-long treatment it places a substantial drag on healthcare resources and it is hoped that biosimilars - usually priced around 20% to 30% lower than their innovator products - could help address.