Korean LG Life Sciences Plans BLA Submission For Biosimilar Somatropin To U.S. FDA
This article was originally published in PharmAsia News
Executive Summary
SEOUL - South Korea's LG Life Sciences completed its Phase III clinical trial of its slow-release recombinant human growth hormone somatropin weekly injection for treating adults with growth hormone deficiency, and is getting its biologics license application ready for U.S. FDA for the new formulation
You may also be interested in...
2011 Preview: Will Korean Pharmas Follow Japanese Pharmas Lead To Survive Harsh Environment At Home?
SEOUL - Pricing pressure and increased government oversight of irregular business activities could prompt Korean pharmaceutical companies to focus on new growth strategies for 2011 such as cooperative deals with multinational companies and exports into new emerging markets like China, according to Korean analysts
2011 Preview: Will Korean Pharmas Follow Japanese Pharmas Lead To Survive Harsh Environment At Home?
SEOUL - Pricing pressure and increased government oversight of irregular business activities could prompt Korean pharmaceutical companies to focus on new growth strategies for 2011 such as cooperative deals with multinational companies and exports into new emerging markets like China, according to Korean analysts
Korea FDA Unveils Initial Biosimilar Guidance; Final Guidelines To Be Released In July
SEOUL - South Korea's FDA is putting the final touches on its EU-modeled initial guidelines for approval and registration of biosimilar products, and anticipates releasing a final version by the end of July