Glenmark Pharmaceuticals, on Tuesday, said the US drug regulator cleared the company's investigational new drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to Novartis anti-asthma biologic XOLAIR or omalizumab in healthy adult volunteers between 18-65 years of age.
The company on Friday said it plans to spend about USD 80 million in next two years as it prepares to take the lead biosimilar molecule bevacizumab into clinical trial.
Aurobindo Pharma forayed into biosimilars with acquisition of four cell culture derived biosimilar products from Switzerland-based TL Biopharmaceutical AG. As part of the deal. TL will supply all the developmental data for four molecules and Aurobindo will develop and market these products globally.
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.
Fosun Pharma complements the injectables platform created by Gland Pharma and provides scope to expand into front-end marketing, said Gland's Vice Chairman and Managing Director Ravi Penmetsa.
Company will continue with tie-ups for biosimilar products. These will first be launched in India and then in other markets, says Satish Reddy, Chairman of Dr Reddy‘s Lab.
The Delhi High Court has allowed pharma firms, Biocon Ltd and Mylan Pharmaceuticals Pvt Ltd, to continue with manufacture and marketing of their breast cancer drug under their brand names 'CANMAb' and 'HERTRAZ'.
Zydus Cadila launched the biosimilar version of Adalimumab, which is the world's first biosimilar made end-to-end in India. Sharvil Patel, Deputy MD, Cadila Healthcare says the important this is to look at access or affordability.
The size of Glargine is expected to be around USD 3-4 billion globally.
Drug major Cipla today said it has launched biosimilar of Etanercept under the brand name 'Etacept' used for treatment of rheumatic disorders in India.
Biocon chief, Kiran Majumdar Shaw told CNBC-TV18 in an exclusive that the Mylan partnership on biosimilars gives them access to certain key markets that could help the company take advantage of the available opportunity in those markets.