Biocon chairman and managing director Kiran Mazumdar-Shaw
India’s largest biopharmaceutical company Biocon inched closer to its goal of launching biosimilars in the US, with the US Food and Drug Administration’s (USFDA) Oncologic Drugs Advisory Committee (ODAC) voting unanimously in favour of a potential blockbuster drug being developed by the Bengaluru-based company and its partner Mylan.
The company, led by India’s richest self-made woman (as per the Forbes India Rich List 2016) Kiran Mazumdar-Shaw, announced on Friday that the ODAC recommended approval of Biocon and Mylan’s proposed biosimilar Trastuzumab, which is used for the treatment of breast cancer.
“Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar Trastuzumab is highly similar to Herceptin (the original drug), in line with the FDA assessment provided in the pre-meeting briefing documents,” Biocon said in a statement to the bourses.
The Street, which for long had accorded a lower valuation to Biocon than some other small-molecule generic drugmakers due the relative immediacy of the latter’s returns on investment, has been bullish on Biocon since its biosimilars program started gathering steam. On Friday as well, Biocon’s shares outperformed the market. At 2:36 pm, Biocon’s shares were trading at Rs 399.70 apiece, up 9.01 percent, on the BSE. The benchmark S&P BSE Sensex was down 0.13 percent at the same time at 31,990.18 points.
To be sure, this ODAC’s recommendation is only one – though important – step towards Trastuzumab’s eventual commercialization in the US, for which it will need a final seal of approval from the USFDA. The drug is also under review (for approval) by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Apart from Trastuzumab, Biocon is also working towards filing for approval pertaining to three other biosimilar drugs across the US and Europe. These drugs have either completed Phase-III trials or are in advanced stages of doing so.
Biocon has a robust pipeline of 10 biosimilar drugs (including different types of insulin) under development with an addressable market size of $60 billion. In order to diversify the risk associated with the development of these products, Biocon has partnered with US generic drug-maker Mylan. The strategic collaboration leverages Biocon’s development and manufacturing capabilities and Mylan’s regulatory and commercial expertise.
Arun Chandavarkar, Biocon’s chief executive officer and joint managing director said in the company’s statement issued Friday that the ODAC’s endorsement brought the company a step closer to “addressing the critical needs of cancer patients in the US.”
“We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers,” Chandavarkar said.