Aurobindo received its first marketing authorisation for the biosimilar drug trastuzumab, which is used for breast cancer treatment, in the Indian market in the current financial year. 

“We have promptly applied for a manufacturing license. which we expect to obtain very soon. So, the plan is to manufacture the batches and launch the product in the second half of this year [FY25] into the domestic market,’’ Satakarni Makkapati, CEO - Biosmilars, Aurobindo Pharma said. 

The product, which is used in treating some types of early and metastatic breast cancers, is also filed with the European Medicines Agency by the Hyderabad-based Aurobindo, and the review procedure has already started. The filing for the US is in progress, and the company is expecting to complete the USFDA filing also in the next three months.

According to Makkapati, if  the procedure unfolds well with the European Medicines Agency without any glitches or without any additional data requirements, a decision may be made towards the end of Q3 or early Q4 of FY25

In July last year, Aurobindo Pharma announced that the breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its wholly owned subsidiary company, Curateq Biologics Private Limited, has met its primary endpoint in Phase 3 clinical trial has shown equivalent efficacy to Herceptin in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile.

Related Topics