EU regulator accepts USV’s application for biosimilar pegfilgrastim
Mumbai: The European Medicines Agency (EMA) has accepted for review of Mumbai-based pharmaceutical company USV Pvt. Ltd’s marketing application for biosimilar pegfilgrastim. The product is a biosimilar to Amgen Inc.’s chemotherapy drug Neulasta.
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.
“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 application for pegfilgrastim with the US FDA (Food and Drug Administration),” Prashant Tewari, managing director of USV told Mint.
According to data on Amgen’s website, Neulasta had global sales $4.65 billion in 2016, of which US sales were $3.9 billion, and rest of the world sales, which includes Europe, were $723 million.
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, Tewari said.
The Mumbai-based company has two other biosimilars in pipeline but they haven’t yet reached the clinical studies stage, he said.
However, analysts believe that European market for pegfilgrastim will be competitive.
“Europe is not a very big market and for pegfilgrastim, it will be a crowded market. It is also a difficult market to penetrate because of varying competitive and regulatory dynamics in different countries. This development can be seen more as a validation of USV’s skillset in biosimilars,” Vishal Manchanda, analyst at Nirmal Bang Securities, said.
USV plans to gradually increase its presence in international markets. The company expects to clock revenue of Rs3,000 crore in the current financial year, of which about Rs2,400 crore will come from Indian market, Tewari said.
The company spends 6% of its revenue on research and development (R&D) of generics, complex generics and biosimilars.
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.