Aurobindo Pharma’s biosimilar subsidiary CuraTeQ Biologics Private Limited has received a key regulatory recommendation from the Subject Expert Committee of CDSCO for its Bevacizumab concentrate for solution for infusion, marking an important step toward expanding India’s cancer biosimilar portfolio. The recommendation relates to Bevacizumab DP 25 mg/mL, available in 100 mg/4 mL and 400 mg/16 mL vial presentations.
According to the CDSCO Subject Expert Committee’s oncology meeting recommendations dated April 22, 2026, CuraTeQ presented its proposal seeking permission to manufacture and market the Bevacizumab biosimilar in India. The submission was based on comparative Phase I and Phase III clinical trial results conducted in India on metastatic colorectal cancer patients. After reviewing the data, the committee recommended granting permission to manufacture and market the product for the treatment of metastatic colorectal cancer, subject to the condition that the company conducts a Phase IV study in India.
Bevacizumab is a widely used oncology biologic that works by blocking tumour angiogenesis — the formation of new blood vessels that feed cancer growth. The originator product, Avastin, is marketed by Roche/Genentech, while biosimilar versions are developed to offer comparable quality, safety and efficacy at potentially lower cost. For a country like India, where cancer treatment costs remain a major burden for many families, domestic biosimilars can play an important role in improving access to advanced therapies.
The CDSCO recommendation is especially significant because Bevacizumab is used in major cancer indications, including colorectal and lung cancers. In CuraTeQ’s Indian regulatory pathway, the current recommendation is tied specifically to metastatic colorectal cancer, one of the major cancer burdens requiring long-duration and often expensive treatment. The committee has asked the company to submit the Phase IV clinical trial protocol to CDSCO within three months of receiving marketing authorisation permission.
The development also comes shortly after CuraTeQ received a Notice of Compliance from Health Canada for Bevqolva, its Bevacizumab biosimilar. Health Canada’s approval confirmed that the biosimilar met regulatory standards for safety, efficacy and quality comparable to the reference biologic under Canadian rules. The product is available in 100 mg and 400 mg formulations, and Aurobindo has said CuraTeQ has additional biosimilar applications under review in Canada.
For Aurobindo Pharma, CuraTeQ’s progress strengthens its position in the global biosimilar market, a segment that is becoming increasingly important as high-cost biologic medicines lose exclusivity and healthcare systems look for more affordable treatment alternatives. Biosimilars require sophisticated manufacturing, clinical comparability data, quality controls and regulatory scrutiny, making them a higher-value segment compared with conventional generic medicines.
For India’s healthcare system, the potential entry of another Bevacizumab biosimilar could support competition in oncology therapy and reduce dependence on expensive imported biologics. The Phase IV requirement also reflects the regulator’s focus on post-marketing safety and effectiveness data in Indian patients, which is important for strengthening confidence in biosimilar use among oncologists and patients.
CuraTeQ’s CDSCO committee recommendation therefore represents more than a company-level regulatory milestone. It signals India’s growing capability in complex biologics, cancer biosimilars and advanced pharmaceutical manufacturing — areas that will be central to making modern cancer care more affordable and accessible.
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