Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.
This week, Novartis announced that the European Commission (EC) approved a label update for secukinumab, sold as Cosentyx. Secukinumab is a targeted biologic therapy for the treatment of psoriatic arthritis (PsA) that inhibits IL-17A, a cytokine involved in inflammation of entheses.
According to Novartis, the label update is significant, as PsA can lead to mobility loss and irreversible joint damage if not treated properly. PsA is a chronic, progressive disease that leads to pain and fatigue as well as activity impairment and significant mobility loss due to structural damage.
“Cosentyx has shown that it can slow the progression of joint damage inflicted by psoriatic arthritis, which can lead to significant mobility loss for patients,” said Paul Emery, professor of rheumatology at the University of Leeds in the United Kingdom.
The update includes dosing flexibility of up to 300 mg based on clinical response that will provide clinicians with dosing flexibility, as well as 24-week structural disease progression data with subcutaneous regimens demonstrating that secukinumab inhibits the progression of joint damage in PsA.
The trial, FUTURE 5, is the largest phase 3 study for a biologic conducted in PsA to date, with an enrollment of 996 patients. The study found that nearly 90% of patients treated with 300 mg of secukinumab had no radiographic disease progression at 24 weeks.
“Cosentyx is the only IL-17A inhibitor to demonstrate a 5-year safety and efficacy in phase 3 studies of PsA and [ankylosing spondylitis]. We are reimagining the well-being of patients living with all facets of psoriatic arthritis,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology, and Dermatology.
The updated label applies to all European Union and European Economic Area countries and takes effect immediately.
Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.
Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab
January 14th 2025The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Top 5 Most-Read Rheumatology Articles of 2024
December 30th 2024The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.