CDSCO Approves Phase I Trial for Jeevan Scientific's Bevacizumab Biosimilar in India
核心洞察
India's CDSCO (搜索) panel has granted permission for Jeevan Scientific (搜索) to conduct a Phase I clinical trial of their bevacizumab biosimilar BE1040V, comparing it to Roche's Avastin in healthy subjects.
The approval follows presentation of supporting Phase III safety data from Iran, where the product is already approved and marketed by AryoGen Pharmed.
The double-blind, randomized pharmacokinetic study will evaluate the biosimilar's bioequivalence to the reference product under fasting conditions for export purposes.
India's Central Drugs Standard Control Organisation (CDSCO (搜索)) panel has approved Jeevan Scientific (搜索)'s proposal to conduct a Phase I clinical trial for their bevacizumab biosimilar, marking another step in expanding access to this critical anticancer therapy in the Indian market.
Trial Design and Regulatory Approval
The approved study is designed as "A Phase 1, double-blind, randomized, two-treatment, two-arm, single-period, single-dose, parallel, comparative pharmacokinetic study, of BE1040V injection 400mg/16ml of AryoGen Pharmed., Iran comparing with Avastin 400 mg/16 ml concentrate for solution for infusion of Roche Registration GmbH" in healthy adult subjects under fasting conditions. The trial, designated Protocol No.: 25-025, Version No. 01 dated April 10, 2025, is intended for export purposes.
The CDSCO (搜索) committee's decision came after detailed deliberation of the firm's comprehensive submission, which included supporting data from a Phase III clinical study conducted in Iran with safety findings. The committee noted that the product is already approved in its country of origin, lending additional credibility to the application.
Bevacizumab's Clinical Significance
Bevacizumab is a monoclonal anti-vascular endothelial growth factor antibody used in combination with antineoplastic agents for the treatment of many types of cancer. The drug targets VEGF (搜索), which plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, making it an attractive therapeutic target for anti-cancer therapies.
There is substantial evidence indicating that vascular endothelial growth factor (VEGF (搜索)) is important for the survival and proliferation of cancer cells. As a humanized monoclonal IgG antibody, bevacizumab inhibits angiogenesis by binding and neutralizing VEGF-A (搜索).
Market History and Regulatory Milestones
Bevacizumab gained FDA approval in 2004 for specific types of cancer and became the first antiangiogenic agent introduced to the market. The drug is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer.
The therapy has since received approval from Health Canada on March 24, 2010, and by the European Commission on April 21, 2021, establishing its global therapeutic footprint across major regulatory jurisdictions.