A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…
Clinical Trial of Ixekizumab for Psoriatic Arthritis Shows Positive Results
A study found that ixekizumab decreases disease activity and increases physical function in biologic-naive patients with active psoriatic arthritis…
Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…
Do RA Patients in Clinical Trials for Biologics Represent the Average?
It’s estimated that a majority of patients with rheumatoid arthritis (RA) have been exposed to biologic treatments. However, the randomized controlled trials demonstrating the safety and efficacy of these biologic agents have strict participant eligibility requirements. New research has examined the requirements of 30 trials for biologics and applied those standards to two large clinical cohorts. The result: A majority of these RA patients did not satisfy the criteria…
Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…
FDA Approves Ustekinumab for Crohn’s Disease
(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…
FDA Approves Adalimumab-atto, a Biosimilar of Humira
WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis
In a clinical trial, subcutaneous abaloparatide has proved effective in treating postmenopausal women with osteoporosis. Also in the U.K., draft guidelines for treating ankylosing spondylitis will recommend the use of secukinumab…
Potential Benefits, Pitfalls of Biosimilars Reviewed at EULAR 2016
LONDON—The availability of a biosimilar form of infliximab has dramatically increased the number of Norwegians taking one form or another of the drug, an expert on biosimilars said in a debate-style session at the Annual Congress of the European League Against Rheumatism (EULAR 2016). The expanded uptake of Remicade (infliximab) and its biosimilar, Remsima (international…
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