Aurobindo Pharma has achieved a significant milestone in its efforts to combat breast cancer with the acquisition of its first marketing authorization for the biosimilar drug trastuzumab in the Indian market during the current financial year. Trastuzumab, a vital medication in breast cancer treatment, is poised to make a substantial impact in the domestic healthcare landscape.
Satakarni Makkapati, CEO – Biosimilars at Aurobindo Pharma, expressed the company’s proactive approach, stating, “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.”
Trastuzumab, utilized in the treatment of certain types of early and metastatic breast cancers, holds promise in addressing critical medical needs. Aurobindo Pharma has extended its reach beyond Indian borders, filing the product with the European Medicines Agency, with the review process already underway. Concurrently, the company is in the process of filing for approval from the US Food and Drug Administration (USFDA), with expectations to complete the filing within the next three months.
Makkapati outlined the potential timeline for regulatory decisions, stating, “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.”
Aurobindo Pharma’s commitment to combating breast cancer was underscored in July last year when it announced positive results from the Phase 3 clinical trial of its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin). Developed by its wholly-owned subsidiary, Curateq Biologics Private Limited, the product demonstrated equivalent efficacy to Herceptin concerning its clinical response (overall response rate, ORR), in addition to exhibiting a comparable safety profile.
The authorization marks a significant step forward for Aurobindo Pharma in its mission to provide accessible and effective treatment options for breast cancer patients, both in India and globally.
