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.
The European Commission has approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union, and the first major new therapeutic option in 60 years.
New psoriasis treatment guidelines released this month by the American Academy of Dermatology and the National Psoriasis Foundation outline the use of biologics in treating and managing psoriasis.
A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.
This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.
As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders. 
Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.
Adherence and persistence rates for biologic drugs are still low in the United States, leading to suboptimal patient outcomes and putting a substantial burden on the healthcare system.

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