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Kiran Mazumdar Shaw-led Biocon is only one step away from securing the US Food and Drug Administration's (FDA's) approval for its first biologic drug.
On Thursday, the FDA's Oncologic Drug Advisory Committee (ODAC) recommended approval of Biocon's proposed biosimilar Trastuzumab, which is indicated for certain types of breast cancer. A biosimilar is a copy of an innovative biological drug.
The FDA is expected to take a call on approving Biocon's Trastuzumab by September 3 but launch in the US market may not take place until 2019 as the drug is under patent in the country. Trastuzumab is sold by drug maker Roche under brand name Herceptin and has a market size of $2.6 billion in the US.
Biocon is partnering with Mylan for developing a portfolio of biosimilars and insulins. The biosimilar Trastuzumab is one of the six biological products co-developed by Mylan and Biocon. Both the companies have sought product approvals for Trastuzumab in Europe and Japan too.
Biocon introduced Trastuzumab in India in 2014 and also sells it in other emerging markets. In the financial year (FY) 2016-17, the company earned Rs 579 crore revenue from biologics business and biosimilar Trastuzumab was one of the key contributors to the 43 per cent growth in the segment.
Biocon and Mylan are the first to receive FDA advisory committee's approval for their biosimilar Trastuzumab. Other companies in the race to manufacture the drug includes Amgen, Pfizer and Samsung Bioepis.
Biocon stock rose 8.8 per cent on Friday and closed at Rs 399.
"The ODAC's recommendation is an endorsement of Biocon-Mylan's biosimilar Trastuzumab which brings our collaboration a step closer to enable access to a high-quality, affordable biologic option for treating HER2-positive breast cancers in the US. We now look forward to engaging with the US FDA to seek final approval," said Biocon chairperson Kiran Mazumdar Shaw.
"This is a very significant milestone in our journey of 'lab to market' for this affordable therapy. The commercialisation in the US will be driven by Mylan, hence we would not like to comment on any specific product launch details," she said.
The French drug regulator detected lapses during its inspection at Biocon's manufacturing plant in Bengaluru and released its findings last week. The inspection was in view of Biocon's submissions for two biosimilar drugs in Europe. Mazumdar Shaw, however, does not think these findings will pose hurdles for the product approval in the US.
"We believe each regulatory review to be independent, based on their own inspection and regulatory process. The positive outcome of ODAC meeting endorses the safety and efficacy of our biosimilar Trastuzumab in comparison to the reference product," she added.