lpca Laboratories inks agreement for creation of Strategic Biosimilars

lpca Laboratories (Ipca) and US-based Oncobiologics, Inc. have entered into an agreement for creation of a two-part alliance for the development, manufacture and commercialization of biosimilar monoclonal antibody products. Under the first part of the agreement, Ipca will in-license and commercialize biosimilar products for the India and associated markets. These products will be developed by Oncobiologics to USFDA and EU regulatory standards for global commercialization. Initial manufacturing will occur in the USA by Oncobiologics and later by Ipca in India. 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 the first product in 2017. Under the second part of the agreement, Oncobiologics will replicate its Biologics R&D and manufacturing facility in India to create a world-class capability for Ipca for further biosimilar commercialization. The Mumbai R&D facility will be designed for development and commercialization of complex monoclonal antibodies. The Manufacturing facility will be located in Vadodara and will utilize the latest single-use manufacturing platform. The R&D facility will be operational from 2015 and the manufacturing facility will be operational by 2016.