Bevacizumab biosimilar is under clinical development by Celltrion and currently in the Phase III 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 Lung Adenocarcinoma took place on 03 Oct 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 (Vegzelma) is a recombinant humanized monoclonal IgG1 antibody, acts as an anti-neoplastic agent. It is formulated as solution, concentrate solution for intravenous route of administration. Vegzelma is indicated for the treatment in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum, combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer, combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations,  in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer and Recurrent Glioblastoma Multiforme.

Bevacizumab biosimilar (CT-P16) is under development for the treatment of metastatic breast cancer, metastatic colorectal cancer, lung adenocarcinoma and non-squamous non-small cell lung cancer. It is administered intravenously. Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to human vascular endothelial growth factor (VEGF-A).

It is under development for Vegzelma in combination with paclitaxel indicated for first-line treatment of adult patients with metastatic breast cancer. It is under development for Vegzelma in combination with capecitabine indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. It is under development for Vegzelma, in addition to platinum-based chemotherapy, indicated for first-line treatment of adult patients with unresectable advanced, metastatic, or recurrent NSCLC other than predominantly squamous cell histology. It is under development for Vegzelma, in combination with erlotinib, indicated for first-line treatment of adult patients with unresectable advanced, metastatic, or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations. It is under development for Vegzelma, in combination with carboplatin and paclitaxel indicated for the front-line treatment of adult patients with fallopian tube, or primary peritoneal cancer. It is under development for Vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, indicated for treatment of adult patients with fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. It is under development for Vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin indicated for the treatment of adult patients with fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.

Celltrion overview

Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.

Quick View Bevacizumab biosimilar LOA Data

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  • Bevacizumab biosimilar
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  • Oncology
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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.