Viswanath Pilla Moneycontrol News
Pharma stocks, with the exception of Biocon, remained subdued this past week as investors booked profit after recent gains.
Biocon was the pick of the week as the company's partner Mylan got the US FDA's approval to market cancer biosimilar Trastuzumab in the US market. This was first ever biosimilar made by an India drug maker to get a US FDA nod.
The BSE Healthcare index dropped 2.4 percent in the past week, while the BSE Sensex declined 1.3 percent
Biocon was the only big gainer this week, with the stock rising 8.5 percent, while all other pharma stocks declined.
Some of biggest losers were Glenmark (-6.0 percent), Aurobindo Pharma (-5.3 percent), Cadila Healthcare (-3.9 percent), Sun Pharma (-3.5 percent), Cipla (-3.4 percent), Dr Reddy's (-3.0 percent) and Lupin (-1.9 percent).
Here's what kept the sector buzzing:
In a major breakthrough, Mylan and Biocon said that the US FDA has approved Mylan’s Ogivri, a biosimilar to Swiss biotech giant Roche's blockbuster cancer drug Herceptin, co-developed with Biocon.
The American regulator has approved Ogivri for all indications of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.
Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US.
Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted a resubmitted application for their Herceptin biosimilar, as well as one for their copy of Amgen’s chemo drug, Neulasta.
Read More: US gives nod to Biocon-Mylan's biosimilar of cancer drug Herceptin, revenues expected from FY19
Also Read: Biocon shares gain after Mylan gets EMA nod for biosimilars
The US FDA made 7 observations about Biocon's Baddi units as the company failed to thoroughly review any unexplained discrepancy and the failure of a batch.
Read More: Glenmark Pharma slips 3% on observations issued by USFDA for Baddi plant
Dr Reddy's Laboratories on Friday said it has received first cycle new drug application (NDA) approval from the American regulator for its Impoyz cream used in psoriasis treatment. It's the fourth specialty product from Dr.Reddy's.
Read More: Dr Reddy's gets first cycle nod for psoriasis treatment cream
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