Exclusive: ACR Convergence 2024| Focus Rheums

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Biologics/DMARDs

Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs

John Miller  |  

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?

Arthritis Care & Research  |  

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…

FDA Approves Ustekinumab for Crohn’s Disease

Reuters Staff  |  

(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

Reuters Staff  |  

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…

Potential Benefits, Pitfalls of Biosimilars Reviewed at EULAR 2016

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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…

Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

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The use of biosimilars for rheuma­tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

Understanding Prescription Pathways for Biologic Medication Therapy

Andrew Hochradel, PharmD, & the ARHP Practice Committee  |  

Executing evidence-based medicine in the U.S. is challenging, especially utilizing high-cost medications in rheumatologic care. As patients trust their clinicians to be their medical experts, clinicians must trust their care team members to be experts at implementing the care plan. A clinician’s knowledge of human anatomy and physiology is the foundation to understanding pathophysiology. From…