Biocon drops after USFDA delays decision on biosimilar

Biocon fell 1.42% to Rs 339.20 at 11:29 IST on BSE after US drug regulator delayed by three months its decision to review the application filed for a biosimilar version of Roche's breast cancer drug.

Meanwhile, the S&P BSE Sensex was down 91.14 points, or 0.29% to 31,555.32.

On the BSE, 1.09 lakh shares were traded in the counter so far, compared with average daily volumes of 4.35 lakh shares in the past one quarter. The stock had hit a high of Rs 343.80 and a low of Rs 336.50 so far during the day. The stock hit a record high of Rs 424.15 on 19 July 2017. The stock hit a 52-week low of Rs 267.57 on 9 November 2016.

The stock had underperformed the market over the past one month till 30 August 2017, falling 8.69% compared with 2.85% decline in the Sensex. The scrip had outperformed the market in past one quarter, rising 7.92% as against Sensex's 1.63% rise. The scrip had outperformed the market in past one year, rising 12.58% as against Sensex's 11.23% rise.

The large-cap company has equity capital of Rs 300 crore. Face value per share is Rs 5.

Biocon announced after market hours yesterday, 30 August 2017, that the US Food and Drug Administration (USFDA) has delayed by three months its decision on whether it will approve Biocon and Mylan's breast cancer biosimilar drug while it reviews additional information submitted by the companies. The approval was earlier expected on 3 September 2017.

USFDA has notified Mylan it will extend the target action date for their application of the drug, Trastuzumab, to 3 December 2017, Biocon said. This is in order to review some clarificatory information submitted to the regulator as part of the application review process, a Biocon spokesperson stated in a statement. This three month extension has no impact on the anticipated timetable for commercialisation of this product in the US, he added.

Biocon and Mylan have together developed the trastuzumab biosimilar, which is a copy of a complex biologic drug developed by Swiss biotech giant Roche.

On a consolidated basis, net profit of Biocon declined 51.2% to Rs 81.30 crore on 5.6% decline in net sales to Rs 927.40 crore in Q1 June 2017 over Q1 June 2016.

Biocon is India's largest and fully-integrated, innovation-led biopharmaceutical company.

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