Indian biopharma company Intas Pharmaceuticals' wholly-owned subsidiary Accord Healthcare is set to be the first integrated player to launch a pegfilgrastim biosimilar across Europe after nearly being given the regulatory green light for Pelgraz (pegfilgrastim).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last Friday issued a positive opinion for Accord's Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. The current market for pegfilgrastim, sold by Amgen’s (Nasdaq: AMGN) as Neulasta, in the European Union is about 500 million euros ($586 million) a year.
Intas Pharmaceuticals will manufacture Pelgraz in its own state-of-the-art production facility. Intas has deep experience with biosimilar medicines. As of July 2018, Intas has 12 different biosimiliars approved in various markets across the world. This reflects a long-standing commitment of Intas to develop, manufacture and market biosimilars.
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