Biocon will be filing for regulatory approvals in key developed markets in a phased manner during 2016 for four biosimilars
India's largest biopharma company, Biocon, is gearing up to enter the regulated markets of the US and the UK with a portfolio of biosimilars in the wake of clinical progress in its partnered programmes with US generics major Mylan. The partnership has a strong portfolio of generic insulin analogues and biosimilars, including monoclonal antibodies (MAbs) and recombinant proteins at various stages of development.
The Biocon/Mylan partnership includes six biosimilar programmes (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogues (glargine, lispro and aspart). Five of the biosimilar programmes have successfully completed Phase I clinical trials, and four are in active Phase III testing. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the US and Europe in 2016.
Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said that two molecules – pegfilgrastim (PEG-G-CSF), Amgen’s Neulasta; and adalimumab, AbbVie’s Humira – have entered global Phase III clinical trials. The addressable market for Biocon in the UK and US is more than US$30bn, and the filings are expected to provide the company with an early mover advantage in key developed markets.
Biocon will be filing for regulatory approvals in these markets in a phased manner during 2016 for four biosimilars: trastuzumab (to treat breast cancer), pegfilgrastim (for chemo-induced neutropenia), adalimumab (for chronic plaque psoriasis) and insulin glargine. The company has made huge R&D investments to develop biosimilars alongside Mylan. It entered into a partnership with Mylan in 2009 for joint research and development of a variety of biosimilar molecules for global markets.
Early this year, Mylan entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals to develop, manufacture and commercialise six of Momenta's current biosimilar candidates, including its biosimilar candidate, Orencia (abatacept). The collaboration with Momenta was seen as highly complementary to Mylan's partnership with Biocon, and was set to position the company as a definitive world leader in biosimilars. This would enable the company to have a broad portfolio of 15 biosimilar/insulin analogue generic products in development and at the scale required to maximise investment in this area.
Mylan has said it would continue to expand and diversify its portfolio into complex products, further differentiating it from other leading generic companies and establishing it at the forefront of the biologics space.
While the collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, it builds upon Mylan's existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities.