Ipca Laboratories Ltd., India and Oncobiologics, Inc., USA announced today the 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 US FDA 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 its 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 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. Ipca is thrilled to partner with Oncobiologics, which brings us excellent biologics development and manufacturing capability, and a deep knowledge of the scientific and quality requirements in the United States," said Chairman and Managing Director of Ipca, Mr. Premchand Godha. "Through this partnership, we look forward to establishing in India a world class biologics operation meeting Indian, US and European Regulatory Standards while leveraging Oncobiologics' ongoing global commercialization for our initial biosimilar pipeline."
"Ipca is one of the leading companies in small-molecule pharmaceuticals in India, with a global footprint. They are distinguished by commercial strength in India and a deep quality culture in their operations, which is essential as we partner to create a strong biologics capability there. Through this partnership we hope to introduce high quality products developed to stringent western regulatory standards at an affordable price," commented Oncobiologics Founder & CEO Pankaj Mohan, Ph.D. MBA.
Financial terms were not disclosed.