Biocon is in focus on USFDA's positive assessment on a biosimilar version of breast cancer drug 'Herceptin'. This comes ahead of the advisory committee meeting tomorrow.
The street thinks this is a big positive but this is just the FDA's view on the clinical data submission and not a product approval. For the biologics license application approval, the agency will consider wider data submission, including good manufacturing practice (GMP) clearance at the Bangalore site, where there are open 483s.
Vishal Manchanda, Nirmal Bang Institutional Equities said if one looked at the FDA briefing document, the tone is definitely positive but this is just the first step and there are still layers of hurdles that Biocon will need to get through before they commercialise it.
Moreover, the launch is also subject to settlement and that could allow them a launch date in 2019 as per speculation.
However, the house currently has a sell on the stock because of their conservative view on the commercial potential of biosimilar opportunities for the company, said Manchanda.
Talking about Q1 earnings expectations, he said the numbers are likely to be lower sequentially in the first quarter the company will have expenses from the Malaysian insulin facility, which could impact the Q1 numbers.
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
