Bio-Thera Solutions, Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE, An Approved Biosimilar Referencing Tocilizumab In Arthritis Research & Therapy
Bio-Thera Solutions, Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE, An Approved Biosimilar Referencing Tocilizumab In Arthritis Research & Therapy
Bio-Thera Solutions和渤健公司发布了TOFIDENCE的三期临床试验数据，TOFIDENCE是参考托珠单抗进行的关节炎研究的批准生物相似药物。
Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra/RoActemra3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE4.
Bio-Thera Solutions, Ltd.今天宣布，与Biogen合作在《关节炎研究与治疗》杂志上发表了一项评估BAT1806/BIIB800的3期临床研究的治疗期2（TP2；研究周24-48）的结果，BAT1806/BIIB800是经批准的Actemra/Roactemra3（托珠单抗）生物仿制药。BAT1806/BIIB800 目前以 TOFIDENCE4 品牌商业化。
- Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800)
- Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2
- 从参考托珠单抗改为TOFIDENCE（BAT1806/BIIB800）后，在治疗期 2（TP2，第 24-48 周）中保持了相似的临床疗效和安全性
- 总体而言，3 期临床数据表明 TOFIDENCE（BAT1806/BIIB800）和参考托珠单抗在切换前后的生物相似性。1,2