Ahmedabad-based Intas Pharmaceuticals becomes the first Indian company to launch a biosimilar in highly regulated markets like the EU, US and Japan. The company today announced that they have launched their first biosimilar, filgrastim, in Europe, through their wholly owned subsidiary Accord Healthcare.
The product has recently been introduced under the brand Accofil and has already won two, in Netherlands and UK respectively, the company statement claimed. "In addition, Intas is also the only company from India to have two of its products, filgrastim and peg-filgrastim filed for registration in the US, through its collaboration partner," the statement added.
Accofil is a biosimilar product of Neupogen (filgrastim) and will offer patients cost effective therapy that is comparable in quality, safety and efficacy. Accofil is indicated for the treatment of reduction in the duration of neutropenia and the incidence of febrile neutropenia, mobilisation of peripheral blood progenitor cells, severe congenital, cyclic, or idiopathic neutropenia and persistent neutropenia in patients with advanced HIV infection.
Binish Chudgar, vice-chairman of Intas said, "Accofil (filgrastim), which was developed at our own laboratories and manufactured at our own cGMP approved site in Ahmedabad, showcases our expertise in biopharmaceutical development and its manufacture. This is only the first of many biological products that we will launch in EU and other regulated markets over the next few years."
Intas has earlier lunched its first product in the domestic market in 2004. The company has eight biosimilar products in the market, including one monoclonal antibody MABTAS (rituximab).The company also has one of the richest pipeline of future products, that will enable it to continue to provide cost effective biosimilar alternates to imported and expensive biologic therapies, for the Indian population. Intas Pharma's biologics manufacturing facility accredited by the European Health Authority.
The company's operations range from API to formulation development to large-scale commercial manufacturing to cater to global requirements.
In the domestic market Intas has a strong presence in chronic therapeutic segments and is currently ranked as the 12th as per December 2014 MAT figures. For the financial year ending March 2015, Intas group has recorded turnover of about Rs 5,200 crore at 27 per cent CAGR over the last five years.