The collaboration announced yesterday will see the Indian small molecule maker initially in-license and commercialise a range of monoclonal antibody biosimilars developed and manufactured by Oncobiologics from its facilities in Cranbury, New Jersey.
In addition, Ipca create a new R&D facility in Mumbai that will be modelled on the Oncobiologics facility according to the US firm's VP Business Development, Stephen McAndrew.
“The design infrastructure, training and know-how will occur via direct transfer in the US initially,” he told Biopharma-Reporter.com.
He added over time “the manufacturing will be ‘tech transferred’ to India so that biologics manufacturing costs can be minimized, but only after establishing high-quality expertise (via on-site training) and establishing appropriate quality-control systems.”
Oncobiologics is developing its products and looking for commercial partners across different global regions and, according to McAndrew, “Ipca was selected primarily because it is one of the fastest-growing small molecule pharmaceutical companies in the Indian subcontinent.
“India is a large and important market with a need for therapeutically important biologics,” he continued, adding: “A key element of Ipca’s going forward business strategy is to expand into biologics, so this represented an excellent fit for both companies.”
Biosimilars have become a key focus in India and a version of Roche’s Herceptin - developed and manufactured by Biocon and Mylan - was approved by the Drug Controller General in December last year.
The terms of the agreement stipulate the specific drugs being developed could not be disclosed but McAndrew revealed to us “they are the leading monoclonal antibody products in Oncobiologics’ biosimilar pipeline and represent significant commercial potential.”
This would include biosimilars of AbbVie’s Humira, Roche’s Avastin, Rituxan and Herceptin, and Lilly’s Erbitux, all of which are currently in preclinical development according to Oncobiologics’ website.
Last August, Oncobiologics signed a pact with inVentiv Health in order to employ a risk-sharing partnership to bring some of these biosimilars to market, with the contract research organisation running and offering bioanalytical support for clinical trials of these drugs.