Search results for: biosimilar

Most Rheumatologists Want FDA to Better Regulate Biosimilars

Richard Quinn | July 24, 2015

In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…

Biosimilar Drug Updates Reported from EULAR

Michele B. Kaufman, PharmD, BCGP | July 8, 2015

At the 2015 meeting of the European League Against Rheumatism in June, multiple studies were presented comparing the use of different biosimilar and biologic drugs in treating rheumatoid arthritis…

Biosimilars for RA Studied in Multiple Trials

Michele B. Kaufman, PharmD, BCGP | June 17, 2015

Biosimilars for etanercept and sarilumab are being examined in multiple Phase 3 trials for their effects in RA and psoriasis patients.

Antibodies to Remicade Cross-React with Biosimilar Remsima

Will Boggs, MD | May 28, 2015

NEW YORK (Reuters Health)—Antibodies to infliximab in patients with inflammatory bowel disease (IBD) treated with Janssen’s Remicade cross-react with the biosimilar Remsima from Celltrion (distributed as Inflectra by Hospira in the U.S.), researchers from Israel report. “The cross-reactivity of anti-Remicade antibodies with Remsima attests to shared immune triggering points (epitopes) on these two agents, and…

First Biosimilar Drugs Approved in U.S., Canada

Michele B. Kaufman, PharmD, BCGP | May 15, 2015

The first biosmilar products have been approved in the U.S. and Canada, following Europe’s early lead. Canada approved its first biosimilar monoclonal antibody (mAb) therapy, known as Inflectra (infliximab), on March 30, 2015.1 In Canada, biosimilars are being called subsequent entry biologic (SEB) agents. Inflectra is approved for treating patients with rheumatoid arthritis (RA), ankylosing…

Biosimilar for Infliximab Launched in Europe

Michele B. Kaufman, PharmD, BCGP | April 1, 2015

Plus, updates on arhalofenate, ALO-02, and other rheumatology drug news, safety information

The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market

Richard Quinn | March 17, 2015

With the U.S. FDA’s first approval of a biosimilar drug earlier this month, rheumatologists stress the need to ensure safety, efficacy of such drugs in treating rheumatic diseases

EULAR 2014: Biosimilar Drug Production Raises Concerns

Thomas R. Collins | August 1, 2014

Rheumatology experts question biosimilars’ safety, efficacy given their complex production process

Biosimilar Drugs Face Challenges to Reach the U.S. Market

Kathleen Louden | March 8, 2012

To date, the FDA has not approved a biosimilar product. In its own discussion of the merits and obstacles to biosimilar drugs, the ACR sponsored a panel session titled, “Biosimilar Products in the U.S. Market: Fact or Fiction?” at the 2011 ACR/ARHP Annual Scientific Meeting here in November.

Encourage Physical Activity During Rheumatic Disease Awareness Month

Vanessa Caceres | August 25, 2025

This year’s Rheumatic Disease Awareness Month encourages rheumatology professionals to collaborate with patients on physical activity routines that benefit their health.