Industry Trend Analysis - Sandoz Agreement Recognises Biocon's Biosimilar Abilities - MAR 2018

BMI View: This agreement highlights a growing recognition within the industry of Biocon ' s ability to develop, manufacture and commercialise biosimilars that can be approved in the well - regulated markets of the US and EU. For Sandoz, a reduced R&D spend on new biosimilars can be expected, boosting the bottom line for resulting product sales. With this agreement, Biocon is now additionally central to the biosimilar outlook for both Sandoz and Mylan, two of the early leaders in the market. This will place Biocon advantageously as the global market develops.

Sandoz ( Novartis) is entering into a global partnership with India-based Biocon to develop, manufacture and commercialise several biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for the products, and will have a cost and profit share arrangement globally. Worldwide commercialisation responsibilities will be divided and each company's strengths will be leveraged within specific geographies. Sandoz will lead commercialisation in North America and the EU, while Biocon will lead commercialisation in the rest of the world.

The firms noted that Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogues from development to commercialisation. The collaboration with Sandoz builds upon Biocon's successful progress in its existing global biosimilars programme. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India, and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets; and it was the first Indian company to have a biosimilar approved by the US FDA.

Gulf Exists Between Sandoz And Biocon Biosimilar Sales
Sandoz And Biocon Biosimilar Sales (USDmn For Comparison)
Source: Biocon, Novartis, BMI

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