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Aurobindo Pharma obtains approval to market Trastuzumab biosimilar in India

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In Short:

Indian pharmaceutical company Aurobindo received marketing approval for its breast cancer treatment drug, trastuzumab. The company plans to begin manufacturing and launch the product in the domestic market by the second half of the year. They have also filed with the European Medicines Agency and are progressing with filing in the US. Aurobindo’s CEO is optimistic about a positive decision by the end of FY25.

Aurobindo Pharma Receives First Marketing Authorization for Trastuzumab Biosimilar in India

Exciting news from Aurobindo Pharma as they received their first marketing authorization for the biosimilar drug trastuzumab in the Indian market this financial year. This drug is used in the treatment of breast cancer and is a significant development for the company.

Manufacturing and Launch Plans

CEO of Biosimilars at Aurobindo Pharma, Satakarni Makkapati, shared their plans moving forward. They have applied for a manufacturing license and are expecting to obtain it very soon. The goal is to manufacture batches of the drug and launch it in the domestic market in the second half of this year [FY25].

Global Reach

Not stopping at just the Indian market, Aurobindo has also filed for approval with the European Medicines Agency. The review process is already underway. In addition, the company is in the process of filing for approval with the USFDA, with expectations to complete the filing within the next three months.

Next Steps

Makkapati expressed optimism about the process with the European Medicines Agency and hinted at a potential decision by the end of Q3 or early Q4 of FY25 if everything goes smoothly without any additional data requirements.

Successful Clinical Trial

Last July, Aurobindo Pharma announced the successful Phase 3 clinical trial results for their breast cancer biosimilar product, BP02. Developed by their subsidiary, Curateq Biologics Private Limited, the drug showed equivalent efficacy to Herceptin, a leading breast cancer treatment, along with a comparable safety profile.

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