IPCA inks pact with US-based Oncobiologics for biosimilars

IPCA Laboratories has entered into a two-part alliance with US-based Oncobiologics Inc for development, manufacture and commercialisation of biosimilar monoclonal antibody products. Under the first part of the agreement, Ipca will in-licence and commercialise biosimilar products for India and associated markets.
 
"These products will be developed by Oncobiologics to the US Food and Drug Administration (US FDA) and European Union regulatory standards for global commercialisation. Initial manufacturing will occur in the US by Oncobiologics and later by IPCA in India," said IPCA in a press release.
 
The biologics covered by the agreement are among the most popular therapies in the world for immunology and oncology disease indications. The partnership is planning to launch its first product in 2017.
 
Under the second phase of partnership, Oncobiologics will replicate its Biologics R&D and manufacturing facility in India to create a world-class capability for Ipca for further biosimilar commercialisation. The Mumbai R&D facility will be designed for development and commercialisation of complex monoclonal antibodies. The manufacturing facility will be located in Vadodara and will utilise the latest single-use manufacturing platform.
 
The R&D facility will be operational in 2015 and the manufacturing facility will be operational by 2016.
 
“This partnership is an important step toward introducing affordable, high-quality biotherapeutics to India. Through this partnership, we look forward to establish in India a world class biologics operation meeting Indian, US and European regulatory standards, while leveraging Oncobiologics’ ongoing global commercialisation for our initial biosimilar pipeline,” said Premchand Godha, CMD, IPCA Laboratories, in the press release.