Dermatology

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
A recent study found no difference in the risk of developing atrial fibrillation (AF) or major adverse cardiovascular events (MACE) associated with ustekinumab versus anti–tumor necrosis factor (anti-TNF) therapy in patients with psoriasis or psoriatic arthritis.
Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).
Given the cost of the brand-name drug, there is interest among providers, particularly in contexts with limited resources, in using a biosimilar rituximab to treat pemphigus, and recently, 2 studies reported on the use of biosimilar rituximab in treating this disease.
Treatment with the biosimilar, the investigators concluded, resulted in comparable, maintained quality of life improvements that were not impacted by a switch from the reference product.
Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.
This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.
The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira).
Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.
Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.

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