Rheumatology

Biosimilar Etanercept, LBEC0101, Is Safe and Effective Up to Week 100 in RA

August 15th 2019

By Kelly Davio

LG Chem’s biosimilar etanercept, LBEC0101, referencing Enbrel, recently gained approval in Japan and the Republic of Korea. Among the data that led to its authorization were those deriving from a phase 3 study that demonstrated the biosimilar had equivalent efficacy and a comparable safety profile to the reference product. Recently, researchers reported on a single-arm, open-label extension study in patients with rheumatoid arthritis (RA) who completed the 52-week phase 3 study.

Bio-Thera Begins Phase 1 Study of Proposed Golimumab Biosimilar

August 14th 2019

By The Center for Biosimilars Staff

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

Fresenius Kabi's Biosimilar Adalimumab, Idacio, Is Similar to Humira in RA in Terms of Safety

August 13th 2019

By Kelly Davio

This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.

Patients Who Receive Positively Framed Biosimilar Information More Than Twice as Likely to Accept a Switch

August 11th 2019

By Kelly Davio

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.

Extension Study Shows Cyltezo Has Similar Efficacy, Safety, Immunogenicity as Humira at 2 Years

August 9th 2019

By Allison Inserro

The study was conducted in patients with moderately to severely active rheumatoid arthritis who previously completed the VOLTAIRE-RA study.

UK Group Reports on a Successful Switch to Biosimilar Etanercept

August 7th 2019

By Allison Inserro

Anti–tumor necrosis factor medicines are one of the costliest drugs for many health systems, and in the United Kingdom, a recent article described how one clinical commissioning group managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.

Systematic Review Underscores the Safety and Efficacy of SB4 in Both Switched and New Patients

August 6th 2019

By Kelly Davio

Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.

Study Finds Strong Retention at 4 Years for Patients With AS Treated With CT-P13

August 2nd 2019

By Kelly Davio

Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.

Celltrion Begins Recruiting US Patients for Phase 3 Study of Subcutaneous CT-P13

August 1st 2019

By Kelly Davio

Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.

Biosimilar Rituximab Appears to Be Safe in Mixed Cryoglobulinemic Vasculitis

July 27th 2019

Mixed cryoglobulinemic vasculitis—a rare disorder that is characterized by the presence of abnormal proteins in the blood that become insoluble at low temperatures and restrict blood flow—may be successfully managed with the use of rituximab as a generally well tolerated, glucocorticoid-sparing therapy.