Biocon's chairperson and managing director Kiran Mazumdar-Shaw said “Biocon and Mylan have the largest portfolio of biosimilars. The global biosimilar market opens up a $ 30 billion opportunity and there are only a few players in the space. Therefore, Biocon and Mylan are in the race to grab a substantial portion of the developed market opportunity in the US and European Union.”
“As an innovation driven organisation, we continued to step up our investments in R&D. During Q2FY16, R&D spends at Rs. 57 crore from Rs. 35 crore represented an increase of 64 per cent YoY, largely on account of the clinical advancement of several biosimilars and novel programmes. Our R&D expenses grew with further advancement of global clinical development of generic insulin glargine and four other biosimilar programmes. At a gross level, we invested Rs. 90 crore on a quarterly basis. On a half yearly basis these investments grew from Rs. 66 crore to Rs. 107 crore registering a 62 per cent growth at the profit and loss level. For the first half of this fiscal, R&D expenses grew to Rs. 183 crore from Rs. 147 crore in the last H1 fiscal,” said Shaw at the Q2 FY 2016 conference call.
R&D advancement of biosimilars is positioning us as a key player in both the developed and emerging markets. Most Indian companies are currently focusing on domestic market opportunity with biosimilars, she said.
Biocon’s four biosimilars programmes partnered with Mylan, have made good clinical progress this quarter. The patient recruitment in the insulin glargine global phase III trials were completed in the first quarter of this fiscal. Patient recruitment for multi-centric global phase III clinical trials for Pegfilgrastim and Trastuzumab are nearing completion while the global phase III clinical trial for Adalimumab is progressing well across multiple sites. The global phase I PK study for Bevacizumab is approaching completion while the ROW focused phase III trial is advancing as per plan. “The encouraging clinical advancement across all our programmes puts us on track for regulatory filings for some of these molecules in the developed markets of US and Europe, in FY17. Therefore, much of the R&D investments are going in for the co-development programme where Mylan too is investing,” she said.
Under the novel programmes, IN-105, oral insulin will be hereafter referred to as Insulin Tregopil, as per its international non-proprietary name (INN) granted by WHO. We have received the complete study report of the recently concluded trials in the US which indicates the important role played by Insulin Tregopil in post prandial glycemic control. “We are extremely excited with these findings and will decide the future course of this molecule in consultation with our partner BMS. We also plan to submit research papers for publication in peer reviewed international journals,” said the Biocon chief.
Specific to Itolizumab, we are actively engaged with our global clinical advisory team in developing this first-in-class anti-CD6, monoclonal antibody for a range of autoimmune conditions. With procedural delays in developing this molecule in the US, we are now working towards conducting clinical trials in Australia scheduled in a couple of months for which we are awaiting clearances from the Ethics Committee, Shaw said.