Accord Healthcare, an arm of Intas Pharmaceuticals Ltd, will become the first integrated player to launch a pegfilgrastim biosimilar across Europe after it received green signal for Pelgraz, by the Committee for Medicinal Products for Human Use (CHMP), a European drug agency.
In an announcement on Monday, Intas informed that the CHMP issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar for Europe.
The current market for pegfilgrastim in the EU is about half a billion euros, it added. Intas Pharmaceuticals will manufacture Pelgraz at its existing production facility. The company has a biologic plant with EU GMP approval.
The company has 12 different biosimiliars approved in various markets across the world as of July.
Intas was the first Indian company to launch a biosimilar in Europe and till date remains the only India-based company to have a biosimilar product approved in European markets. The company enjoys about 15 per cent market share for its biological product “Accofil” (Filgrastim) in the EU.
Binish Chudgar, Vice Chairman and Managing Director of Intas Group, said, “Accord launched its first European approved biosimilar product, Accofil, in 2015 and despite being the 6th entrant, it has become a leading supplier of this vital medicine.”
“Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be the first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz,” he added.