Tags : Rituximab

Regulatory

Bayer Reports sNDA Submission to US FDA and MAA to

Shots: The submissions are based on P-III CHRONOS-3 trial evaluating copanlisib + rituximab vs PBO + rituximab in patients with relapsed iNHL in extending PFS, following at least one prior rituximab-containing therapy Results: improvement in 1EPs of PFS, AEs of the combination was generally consistent with previously published data on the individual components of the […]Read More

Biosimilars Clinical Trials

Celltrion Presents Real-World Data of Truxima (biosimilar, rituximab) for Diffuse

Shots: The new data from the post-approval study evaluates the effectiveness & safety of Truxima (CT-P10) in patients with DLBCL in a real-world setting across Europe Results: @30mos. post-index, 67% had not experienced disease progression with OS (74%), three-quarters patients achieved complete or partial response @30mos., well tolerated with AEs while response rates, survival rates […]Read More

Biosimilars

Samsung Biologics and AstraZeneca to Dissolve Rituximab Alliance

Shots: Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly-owned subsidiary, Archigen Biotech, which was solely engaged in the development of SAIT101 (biosimilar, rituximab) Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan […]Read More

Biosimilars Regulatory

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in

Shots: NMPA has approved Halpryza for patients with DLBCL, FL, and CLL in China. The biosimilar is the fourth mAb approved in China following the approval of Tyvyt (biosimilar, sintilimab), Byvasda (biosimilar, bevacizumab) and Sulinno (biosimilar, adalimumab) The clinical efficacy and safety of rituximab in CD20 +ve NHL have been confirmed in multiple large-scale clinical […]Read More

Biosimilars

Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Shots: Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20 Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung […]Read More