Oncobiologics And Ipca Establish New Biosimilars Alliance
Oncobiologics announced that it has entered into a two-part collaboration with Ipca Laboratories for the development, manufacture, and sales of biosimilar monoclonal antibody candidates. No financial details were disclosed by either company.
The agreement has two major parts. Under the terms of the first part of the agreement, Ipca will in-license and commercialize biosimilar products from Oncobiologics for India and related markets. Manufacturing will first take place in the New Jersey site of Oncobiologics and will later be transferred in Ipca’s laboratories in India. Oncobiologics will construct a replication of its Biologics R&D and manufacturing site in Mumbai, India to build production capability for Ipca, as dictated by the second part of the agreement. The facility will be designed to develop and market complex monoclonal antibodies. The R&D site will open in 2015; the manufacturing site is expected to be up and running by 2016.
The partnership will center on biologics intended for immunology and oncology indications. These are developed by Oncobiologics in alignment with U.S. FDA and EU regulatory standards for global marketing. The partners are expecting to launch its first product in 2017.
Chairman and Managing Director of Ipca, Mr. Premchand Godha, said, “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 Laboratories is a pharmaceutical firm based in India with a focus on exports. The company produces Finished Dosage Forms and Active Pharmaceutical Ingredients (APIs) for its clients in almost 130 countries.
“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,” said Oncobiologics Founder & CEO Pankaj Mohan.
Private biopharmaceutical firm Oncobiologics focuses on developing a pipeline of biosimilars and next generation biotherapeutics in oncology, immunology, and immune-oncology. The company is headed by a team of industry experts from firms such as Amgen, Genentech, Pfizer, and Merck among others. Oncobiologics’ last collaboration was with InVentiv Health last year for the clinical development of all assets in its pipeline.