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CLINICAL STUDIES FOR BIOSIMILARS
Civil society organisations urge govt to scrap animal testing in biosimilar developmentCivil society organizations are urging the health ministry to eliminate animal studies in biosimilar development to lower production costs ...
Biocon drops plan to launch weight-loss drugs in China, executive saysBiocon has scrapped its plans to introduce generic versions of Novo Nordisk's Ozempic and Wegovy in China, citing intense local competition...
Revised rules for biosimilar drugs enter the final stretchThe Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in research and m...
Biocon shares in focus after successful results of Yesintek in Phase 3Biocon's shares have risen by 18.31% over the past year. However, year-to-date (YTD), the stock has dropped by 9.59%. In the last six month...
Dr Reddy's Laboratories jumps into the fray for Biogen's biosimilarsDr Reddy's Laboratories (DRL) and Intas Pharmaceuticals, both Indian companies, are reportedly in the race to acquire the biosimilar produc...
Alkem subsidiary Enzene launches adalimumab biosimilar in IndiaEnzene or its parent Alkem which is commercialising the drug didn't announce the price, but said it would be competitively priced.
Dr Reddy's completes clinical studies of its proposed rituximab biosimilar candidateFollowing completion of the full set of clinical studies, Dr Reddy's said it will now prepare to file in the US, European Union and other r...
Shilpa Medicare arm gets NoC to conduct clinical studies for its Biosimilar AfliberceptListed pharmaceutical entity Shilpa Medicare on Monday informed the exchanges that its subsidiary Shilpa Biologicals (SBPL) has received a ...
Irish drug regulator clears Lupin Pune unit after virtual inspectionLupin’s Pune facility is known for its R&D and manufacturing work related to biosimilars.
COVID-19: Novartis to begin HCQ trialsEven as there is still question hanging over the efficacy of hydroxychloroquine (HCQ) as medication for Covid-19, Swiss drug maker Novartis...
Lupin's JV completes global trials for RA biosimilarThe randomised trial of 52 weeks was conducted in 11 countries and included over 500 patients, Lupin said.
Delhi High Court gives Biocon, Mylan green light to market blockbuster biosimilar for three cancersThe court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and M...
Mylan and Biocon make USFDA submission for proposed biosimilar trastuzumabThe submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data that consists of two pharmacokin...
Indian biosimilars market may reach $40 bn by 2030: ReportThe biosimilars opportunity is nascent today and the 2016 estimated market size was only $2.2 billion.
Biocon's biosimilars progressAnalysts gave a thumbs up to Biocon after the company said its copy of biopharmaceutical insulin glargine met the primary targets, which in...
Biocon targets emerging, developed markets with biosimilars"Biocon aims to provide high quality biosimilars to patients across the world, both in emerging and developed markets," Kiran Mazumdar-Shaw...
Biocon, Mylan drug discovery programme to treat cancer, arthritis makes progressBiocon today said two molecules for treating cancer and arthritis under the drug discovery programme with Mylan have entered global Phase 3...