CDSCO approval granted for this breast cancer treatment drug

Its CDSCO approval signifies a positive step towards providing effective treatment options.

January 17, 2024

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Last Updated on September 30, 2024 by The Health Master

CDSCO approval

Aurobindo Pharma Ltd‘s wholly-owned subsidiary, CuraTeQ Biologics, achieved a significant milestone on January 17 as it secured CDSCO Approval for marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for its biosimilar trastuzumab.

In a stock exchange filing, Aurobindo Pharma announced that CureTeQ Biologics received a favorable recommendation for marketing authorization from the Subject Experts Committee (SEC) of CDSCO, the apex drug regulator in India.

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Significance of Biosimilar Trastuzumab

Trastuzumab biosimilar, a humanized monoclonal antibody, plays a crucial role in the treatment of metastatic breast cancer and early breast cancer.

Its CDSCO approval signifies a positive step towards providing effective treatment options.

CDSCO Recommendation

The recommendation from CDSCO’s SEC marks a significant achievement for CuraTeQ Biologics, highlighting the CDSCO approval and acceptance of the biosimilar trastuzumab in the Indian pharmaceutical landscape.

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Technical Information

Aurobindo Pharma informed the bourses that the monoclonal antibody is supplied in single-dose glass vials containing lyophilized powder in dosages of 150 mg and 420 mg as a concentrate for a solution for infusion.

Phase IV Clinical Trial Protocol

As part of the regulatory process, CuraTeQ Biologics is obligated to submit the Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorization.

This step underscores the commitment to ongoing research and development.

Click for Guidance documents for industry

Aurobindo Pharma’s Inspection by USFDA

In recent developments, Aurobindo Pharma’s manufacturing facility in Telangana faced scrutiny from the United States Food and Drug Administration (USFDA), receiving a ‘voluntary action indicated’ classification.

The impact of this classification on Aurobindo Pharma’s operations is a topic of discussion within the pharmaceutical industry.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

What is trastuzumab biosimilar, and how does it differ from the original drug?Trastuzumab biosimilar is a humanized monoclonal antibody used in cancer treatment. While similar to the original drug, biosimilars undergo rigorous testing to ensure efficacy and safety.
What are Phase IV clinical trials, and why are they important for CuraTeQ Biologics?Phase IV clinical trials occur after a drug is approved. They monitor long-term effects and gather additional information, contributing to ongoing research and ensuring safety.
How does the USFDA’s classification of ‘voluntary action indicated’ impact Aurobindo Pharma’s operations?The classification suggests areas for improvement. Aurobindo Pharma will likely address these concerns to maintain high-quality manufacturing standards.
Why is Aurobindo Pharma exploring an IPO for Eugia Pharma Specialities, and what challenges did they face in the past?The IPO aims to raise funds for expansion. Previous attempts to sell Eugia faced challenges related to differences in valuation between Aurobindo Pharma and potential investors.
What are the potential benefits of Aurobindo Pharma’s ₹4,500 crore fundraising goal in 2024?The fundraising goal is expected to contribute to the company’s growth and development, supporting research, manufacturing, and overall financial health.