May 31st 2023
The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.
Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars
November 24th 2020Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.
Research Letter Suggests That Off-label Use May Be Boosting Eculizumab Sales
November 2nd 2019In a research letter appearing this week in JAMA Internal Medicine, authors from Oregon Health and Science University raised the question of whether the “large and increasing revenue from eculizumab” could be tied to off-label use for non-approved indications.
New Data Underscore the Utility of Rituximab in Treating Pemphigus Vulgaris
October 15th 2019Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.
At ANA 2019, Studies Detail the Role of Eculizumab in MG as Competitive Therapies Advance
October 14th 2019While eculizumab is being targeted by multiple biosimilar developers who are in phase 3 clinical trials with their competitive products, spending on eculizumab is reaching concerning levels; as such, it is increasingly important to clarify eculizumab’s place in the treatment paradigm for myasthenia gravis (MG).
First Dornase Alfa Biosimilar Approved and Launched in Russia
September 21st 2019This week, Russian drug maker Generium announced that it has received approval for—and has launched—its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.
New Data From PREVENT Show Benefits of Eculizumab in NMOSD
September 13th 2019During this week’s meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers are presenting new data for eculizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder that typically affects the optic nerves and spinal cord and that can cause significant, irreversible disability.