NEW YORK (Reuters Health)—Psoriasis patients treated with tumor necrosis factor-alpha (TNF) inhibitors may have a lower risk of major cardiovascular (CV) events than those treated with methotrexate (MTX), according to a new study. “The findings do not surprise me. TNF inhibitors control inflammation better than methotrexate,” lead author Dr. Jashin J. Wu of Kaiser Permanente…

Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs
Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…

Sarilumab Approval Stalled; Piclidenoson Promising for Psoriasis
Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…

Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…

Many Patients Discontinue Tofacitinib by Year 1; Fasinumab Promising for Pain
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…
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