Significant biosimilar activities this week include:
June 14: Celltrion presented new data from Phase II trials of a Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib regime for the treatment of relapsed/refractory aggressive B-cell lymphoma. Celltrion reported that the regime was well tolerated by patients.
June 15: Samsung Bioepisannounced it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.
June 16: Henlius Biotech announced the results of Ph III trials of HLX04 (proposed bevacizumab biosimilar) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer. Henlius reported that the study successfully met the primary endpoint.
June 17: the Centre for Biosimilarsreported on a survey presented at a virtual meeting of the European League Against Rheumatism which studied the prescribing habits of French rheumatologists. The survey revealed that many rheumatologists still lack confidence in switching to tumor necrosis factor inhibitor (TNFi) biosimilars.
June 17: Fresenius Kabi received Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.
June 19: Bio-Thera Solutionsannounced China's NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).
June 19: Innovent Biologicsannounced China's NMPA has approved Byvasda® (bevacizumab) for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.