Intas first Indian company to launch biosimilar in EU, US and Japan
The company has launched its first biosimilar, filgrastim, in Europe, through its wholly owned subsidiary Accord Healthcare
Ahmedabad-based Intas Pharmaceuticals has become the first Indian company to launch a biosimilar in the highly regulated markets of the EU, US and Japan. The company launched its first biosimilar, filgrastim, in Europe, through its wholly owned subsidiary Accord Healthcare.
The product has recently been introduced under the brand Accofil and has already won two tenders, in Netherlands and UK respectively, the company said. '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,' it added.
Accofil is a biosimilar product of Neupogen (filgrastim) and aims to offer patients cost-effective therapy that is comparable in quality, safety and efficacy. Accofil is indicated for reducing 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.
'Accofil, which was developed at our own laboratories and manufactured at our own cGMP approved site in Ahmedabad (in Gujarat), showcases our expertise in biopharmaceutical development and its manufacture,' said Binish Chudgar, vice chairman of Intas. 'This is only the first of many biological products that we will launch in the EU and other regulated markets over the next few years.'
Intas launched 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 alternatives to imported and expensive biologic therapies, for the Indian population. Intas Pharma's biologics manufacturing facility is 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 it has a strong presence in chronic therapeutic segments.