Bevacizumab Updates

On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint.  The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients with metastatic colorectal cancer.

 On June 17, 2020, Outlook Therapeutics, Inc. provided a clinical update for ONS-5010/LYTENAVA, Outlook’s investigational ophthalmic formulation of bevacizumab.  Outlook is currently conducting two registration clinical trials for ONS-5010 in support of a 351(a) biologics license application seeking approval for the treatment of wet age-related macular degeneration.  NORSE 1, the first registration clinical trial evaluating ONS-5010’s safety and efficacy, completed enrollment in August 2019, and topline results are expected in August 2020.  The NORSE 2 clinical trial began patient enrollment in July 2019 and is expected to enroll a total of approximately 220 patients. Outlook has also received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials evaluating, among other things, the use of ONS-5010 for treating branch retinal vein occlusion and diabetic macular edema.

 On June 19, 2020, Innovent Biologics, Inc. announced that its bevacizumab biosimilar, BYVASDA, has been approved by China’s National Medical Products Administration for the treatment of advanced non-small cell lung cancer and metastatic colorectal cancer.  As previously reported, in January 2020 Innovent out-licensed the commercial rights of BYVASDA in the United States and Canada to Coherus BioSciences.

 Also on June 19, 2020, Bio-Thera Solutions announced that China’s National Medical Products Administration has accepted the Biologics License Application for its proposed bevacizumab biosimlar, BAT1706.  Bio-Thera seeks commercial licensure for all approved indications of Avastin in China, and reports that it has obtained data through a series of studies demonstrating that BAT1706 is highly similar to Avastin in clinical efficacy and safety.