Mumbai-based USV Pvt. Photo: Hemant Misra/MintMumbai: The European Medicines Agency (EMA) has accepted for review of Mumbai-based pharmaceutical company USV Pvt. The development comes after the EMA accepted for review of Biocon Ltd and Mylan N.V.’s applications for biosimilars pegfilgrastim and trastuzumab on 30 November. The Mumbai-based company has two other biosimilars in pipeline but they haven’t yet reached the clinical studies stage, he said. Apart from biosimilars, USV is looking to file about 8-10 abbreviated new drug applications (ANDA) with the US FDA annually.

Source: Mint December 06, 2017 20:26 UTC