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Biocon cancer drug now only a step away from getting USFDA approval

The FDA is expected to take a call on approving Biocon's Trastuzumab by September 3

Aneesh Phadnis  |  Mumbai 

Kiran Mazumdar Shaw, CMD, Biocon
Kiran Mazumdar Shaw, CMD, Biocon

Kiran Mazumdar Shaw-led 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 A biosimilar is a copy of an innovative biological drug.

The is expected to take a call on approving Biocon's by September 3 but launch in the US market may not take place until 2019 as the drug is under patent in the country. is sold by drug maker Roche under brand name Herceptin and has a market size of $2.6 billion in the US.

is partnering with for developing a portfolio of and The biosimilar is one of the six biological products co-developed by and Both the have sought product approvals for in Europe and Japan too.

introduced 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 was one of the key contributors to the 43 per cent growth in the segment.

and are the first to receive advisory committee's approval for their biosimilar Other in the race to manufacture the drug includes Amgen, and

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 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 to seek final approval," said 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 in comparison to the reference product," she added.

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