News | November 1, 2018

Intas Pharmaceuticals To Be The First To Launch Pegfilgrastim Biosimilar In Europe

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 program 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 % market share for its biological product “Accofil” (Filgrastim) in EU.

Binish Chudgar Vice Chairman and Managing Director of 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 2 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 of 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 realizing its vision of Biosimiliars for Billions.”

About Intas Pharmaceuticals Ltd.
Intas is among the Top 10 Indian pharmaceutical companies and the largest privately held pharmaceutical company in India, with annual turnover of US$ 1.7B - of which more than 70% comes from international operations. Intas is one of the fastest growing multinational of Indian origin and has maintained a 25% CAGR for the last decade.

The group has an extensive geographic footprint with presence in 70 countries worldwide and more than 80% of export revenue coming from US, UK and EU.

In addition to generics formulation, R&D is focused on value added products such as biosimilars, value added and improved generics using novel drug delivery systems (NDDS) and innovative active pharmaceutical ingredients (API). Intas has the largest commercialised portfolio of biosimilars in India and is the first Indian pharmaceutical company to launch a biosimilar in the EU. It has also developed a pipeline of novel improved cancer treating agent (NDDS).

SOURCE: Intas Pharmaceuticals Ltd.