 "Biocon hits new high after USFDA accepts cancer drug biosimilar application")
Biocon rallied around 5% to Rs 1,050, also its fresh record high on BSE in early morning trade, after the company said that the US Food and Drug Administration (USFDA) has accepted Mylan’s biologics licence application for its biosimilar drug to treat breast cancers.
The drug, a proposed biosimilar to branded trastuzumab, will be used to treat breast cancer. The companies expect a decision from FDA by September 3.
Biocon in partnership with Mylan NV, is developing four biosimilars—pegfilgrastim, trastuzumab, adalimumab and insulin glargine—for regulated markets such as Europe and US.
"This is Mylan and Biocon's first US regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide," said Mylan President Rajiv Malik in a statement on Wednesday evening. "We are committed to bringing this product to market and look forward to working with FDA over the next months."
At 09:27 am; the stock was up 4.6% at Rs 1,048 on the BSE. A combined 885,783 shares changed hands on the counter on the BSE and NSE so far.
The drug, a proposed biosimilar to branded trastuzumab, will be used to treat breast cancer. The companies expect a decision from FDA by September 3.
Biocon in partnership with Mylan NV, is developing four biosimilars—pegfilgrastim, trastuzumab, adalimumab and insulin glargine—for regulated markets such as Europe and US.
"This is Mylan and Biocon's first US regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide," said Mylan President Rajiv Malik in a statement on Wednesday evening. "We are committed to bringing this product to market and look forward to working with FDA over the next months."
At 09:27 am; the stock was up 4.6% at Rs 1,048 on the BSE. A combined 885,783 shares changed hands on the counter on the BSE and NSE so far.
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