India Pharma Outlook Team | Tuesday, 11 November 2025
The Oncology Subject Expert Committee (SEC), which is a part of the Central Drugs Standard Control Organisation (CDSCO), has advised that MSN Laboratories Pvt. Ltd. be given the green light to produce and sell Abiraterone Acetate Tablets 1000 mg.
The committee approved the decision after reviewing a bioequivalence (BE) report and receiving a clinical trial waiver justification from the company.
The SEC(Oncology) meeting dated September 23, 2025, also discussed the matter, which was based on the recommendation of July 9, 2024, that had been referred. MSN Laboratories had moved to get permission to manufacture and market the 1000 mg formulation through a BE study that was conducted in a fasting condition. After a thorough examination, the committee was convinced of the BE data and thus gave a nod to the company's request.
Nevertheless, the SEC ordered that MSN Laboratories should carry out a Phase IV clinical trial to monitor the safety and efficacy of the product after it has been launched in the market. The company has been given the directive to send the CDSCO a copy of the trial protocol within three months after product approval.
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Abiraterone acetate is an androgen biosynthesis inhibitor (CYP17 inhibitor) that works by binding to the heme group of 17alpha-hydroxylase and inhibiting the overall enzyme complex CYP17. The drug was originally developed by Janssen, a subsidiary of Johnson & Johnson, and is sold worldwide under the brand name Zytiga.
It is used for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The newly approved 1000 mg dose makes treatment easier as a single daily dose is enough, thus, it is one more step forward in the war against cancer in India.
