The United States Foods and Drug Administration (USFDA) Oncologic Drugs Advisory Committee (ODAC) has recommended an approval of a biosimilar trastuzumab in the US. Trastuzumab is Biocon and Mylan's biosimilar which is a biosimilar version of Herceptin used to treat breast cancer in the US market. Watch accompanying video of Vishal Manchanda of Nirmal Bang Institutional Equities in which he shared his readings and views on the same.
Global healthcare company Mylan has inked a settlement pack with Genentech and Roche in relation to patents for cancer drug Herceptin (Trastuzumab).
The Delhi High Court today told Swiss pharma major Roche that it "cannot hang on to" breast cancer drug Trastuzumab, innovated by it, for the rest of its life after having enjoyed the fruits of its patent.
Attributing the strong show in Q3FY17 to robust performance in biologics, Biocon Chairperson and MD Kiran Mazumdar-Shaw told CNBC-TV18 that Biocon is well poised to be front-runner in biosimilars. The acceptance of biosimilar Trastuzumab by the USFDA is a huge milestone for Mylan and Biocon, she said.
Biocon shares touched a record high of Rs 1,049.50 on Thursday, up nearly 5 percent intraday after the US health regulator has accepted biosimilar application for its proposed cancer drug.
Following US president-elect Donald Trump‘s explosive speech last night where he lambasted the domestic pharma companies for outsourcing work, pharma stocks are likely to be in limelight today.
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
This study was the last major step of a multiple-phased programme to demonstrate that proposed biosimilar trastuzumab meets the criteria for equivalence in comparison to branded trastuzumab.
Biocon is among the companies that gave a good performance in 2016 and the stock surged 80 percent this year. Speaking to CNBC-TV18, Kiran Mazumdar Shaw, CMD of the company, said the company has gained traction in many emerging markets with its biosimilars.
Speaking to CNBC-TV18, Kiran Mazumdar Shaw, CMD of Biocon said huge opportunities exist for Biocon in the US biosimilars market.
The European Medicines Agency (EMA) has accepted to review Mylan and Biocon‘s application for a biosimilar called Trastuzumab, used for certain breast and gastric cancers.
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the presentation of data from the HERITAGE study at ...
These market filings have a market opportunity of USD 40 billion. In particular, Japan offers a market potential of USD 150 million for its insulin product Glargine, says Biocon's Chairman and Managing Director.
It believes that Biocon's (and its partner Mylan) four potential product filings each in the US and EU would add credibility to its pipeline and bring market recognition. Emerging market monetisation is under way, but the US and EU opportunities will take at least two years, according to report.