EU regulator accepts USV's application for biosimilar pegfilgrastim

  • The European Medicines Agency has accepted USV's application seeking to market a biosimilar of Amgen's Neulasta, reported.

  • "Pegfilgrastim is the key product in the biosimilars portfolio that we are developing and acceptance of marketing authorisation application by EMA is a significant milestone," commented USV managing director Prashant Tewari, adding "we are also planning to file application for pegfilgrastim with the [FDA]."

  • Global sales of Neulasta have totalled $4.7 billion for 2017.

  • Tewari noted that while four other drugmakers have requested approval to market biosimilars of Neulasta, the company expects a financial boost from its product.

  • “Europe is not a very big market and for pegfilgrastim, it will be a crowded market," cautioned Vishal Manchanda of Nirmal Bang Securities, adding "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."

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