Etanercept Biosimilar Is Effective, Well-Tolerated for Rheumatoid Arthritis

The study was funded by LG Chem, Mochida Pharmaceutical, and Korea Health Industry Development Institute. LG Chem employs two of the six study authors, and Mochida Pharmaceutical employs another two.

Reference

Matsuno H, Tomomitsu M, Hagino A, et al. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis. 2017 Dec 19. pii: annrheumdis-2017-212172. doi: 10.1136/annrheumdis-2017-212172. [Epub ahead of print]

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…

Information on new approvals and medication safety that rheumatologists need to know

After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…

As a veteran rheumatologist, I remember the clinical trials of etanercept’s (Enbrel’s) efficacy. And when the drug was first approved in 1998, I participated in those clinical trials and realized the effectiveness was astonishing. It was easy to tell which patients were treated with etanercept vs. those who received placebo, even though both groups were…

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