EMA accepts USV’s application

The European Medicines Agency (EMA) has accepted the review of Mumbaibased pharmaceutical company USV Pvt. Ltd’s marketing application for biosimilar pegfilgrastim. The product is a biosimilar to Amgen Inc.’s chemotherapy drug Neulasta.

Pegfilgrastim is administered to patients with certain kinds of cancer to accelerate recovery from chemotherapy treatment. It is also used to boost the white blood cells in the cancer patients.

“Pegfilgrastim is the key product in the biosimilars portfolio that we are developing and acceptance of marketing authorization application by EMA is a significant milestone. We are also planning to file an application for pegfilgrastim with the US FDA (Food and Drug Administration),” said Prashant Tewari, managing director of USV.

Tewari further stated although there are four other companies that have likely filed applications for pegfilgrastim, USV may be able to garner good revenue, which will help in scaling up the company’s biosimilars pipeline.

The Mumbai-based company has two other biosimilars in the pipeline but they have not 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. It currently has 40 products filed in the US and 18 generic drugs have been approved.