Bevacizumab biosimilar is under clinical development by Shanghai Henlius Biotech and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Bevacizumab biosimilar’s likelihood of approval (LoA) and phase transition for Wet (Neovascular / Exudative) Macular Degeneration took place on 13 Apr 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Bevacizumab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Bevacizumab biosimilar overview

Bevacizumab (Hanbeitai) is a recombinant humanized monoclonal IgG1 antibody, acts as an anti-neoplastic agent. It is formulated as solution for intravenous route of administration. Hanbeitai is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). It is under development for solid tumors, hepatocellular carcinoma, diabetic retinopathy and wet age-related macular degeneration, cervical cancer and epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Shanghai Henlius Biotech overview

Shanghai Henlius Biotech (Henlius), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, is a biopharmaceutical company, which is involved in the research, development, production, and marketing of monoclonal antibody products. It develops medicines primarily for oncology, autoimmune and ophthalmic diseases. The company’s key products include Rituximab injection for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma; Trastuzumab for breast cancer, metastatic gastric cancer and metastatic breast cancer; and Adalimumab injection for ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis and uveitis. It also offers Bevacizumab Injection and Serplulimab Injection. Henlius is engaged in developing other products such as HLX14, HLX10, Serplulimab+Chemo, HLX208, HLX13 and HLX71 among others, which are under research and clinical trials. The company operates research and development centers in Shanghai, China, and California, the US. Henlius is headquartered in Shanghai, China.

Quick View Bevacizumab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Bevacizumab biosimilar
Administration Pathway
  • Intravenous
  • Intravitreal
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
  • Ophthalmology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.