In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…
Amgen Files for U.S. Approval of Biosimilar
(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Guselkumab Studied to Treat RA, Plaque Psoriasis
Guselkumab Studied to Treat RA & Plaque Psoriasis Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). On June 11, 2015, at the 2015 meeting of the European League Against…
Biosimilar Drugs for RA Studied in Multiple Trials
Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
Biosimilars for RA Studied in Multiple Trials
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
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…
Biosimilar for Infliximab Launched in Europe
Plus, updates on arhalofenate, ALO-02, and other rheumatology drug news, safety information
The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market
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
Update on Legislation, Advocacy Efforts to Advance Rheumatology
Status of progess to fix sustainable growth rate physician formula, other rheumatology-related issues facing Congress
EULAR 2014: Biosimilar Drug Production Raises Concerns
Rheumatology experts question biosimilars’ safety, efficacy given their complex production process