Pelgraz, a pegylated G-CSF Biosimilar, is the latest addition to its established portfolio of over 30 oncology treatments across Europe
Intas Pharmaceuticals’ wholly owned subsidiary – Accord Healthcare is set to be the first integrated player to launch a pegfilgrastim biosimilar across Europe after being given Green Light for Pelgraz (pegfilgrastim) by CHMP. The Committee for Medicinal Products for Human Use(CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Current market for pegfilgrastim in EU is about half a billion Euro.
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.
The company’s dedicated biologic manufacturing plant was the first in India to gain and maintain EU GMP approval. Intas started its biosimilar programme 15 years ago, and has already launched 12 biologics in India. Intas was the first ever 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. In a short span Intas has garnered about 15 per cent market share for its biological product ‘Accofil’ (Filgrastim) in EU.
Binish Chudgar, Vice Chairman and Managing Director, Intas Group, “Intas/Accord launched its first European approved biosimilar product, Accofil, in 2015 and despite being the 6th entrant has become a leading supplier of this vital medicine. Since then the product has been used over two million times and Intas has gained valuable experience in bringing biosimilar medicines to market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz.”
Emilio Rivera, COO, Intas Biotech,” At Intas Biotech, our mandate is to develop, manufacture and market Biosimiliars of world class quality. We would like our products to be accessible to as many patients as possible. With this approval it brings Intas one step closer in realising its vision of Biosimiliars for billions.”