Aurobindo Pharma said that earlier in April, the European Medicines Agency recommended the marketing authorisation for Dazublys. The Agency gave a positive opinion on Dazublys.
What is Dazublys?
Aurobindo Pharma’s Dazublys is a trastuzumab biosimilar. Simply put, medication is a biological similar version to the original trastuzumab, an antibody drug used for the treatment of breast cancer and gastric cancer.
The medication, used for the cancer treatment, targets the HER2 receptors on the cancer cells that promote the growth of the cancer cells.
The biosimilars are usually developed after the original medication’s patent expires. In case of trastuzumab, the first original brand was Herceptin, which was developed by the American medical company Genentech (Roche).
Aurobindo Pharma’s other European approvals
Aurobindo Pharma said that this is the company’s third biosimilar that has received approval from the European Medicines Agency. The company said that earlier in April, it received approval for Dyrupeg, used to reduce the risk of infection during chemotherapy, and for Zefylti, also used during chemotherapy.
In total, the company has received four approvals in the European Union and one approval in the United Kingdom.
