Wednesday, June 6, 2018 Daily Archives

Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

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Backed by US$260 million, Brii BioSciences is the latest firm benefiting from regulatory and economic changes in China. Insider spoke with expert David Deere to discover why the Chinese market is finally opening up. Funded by a group of six venture capitalists firms, Brii Bio is the latest, and one of the largest, examples of the surge of investment and innovation in Chinese biotech. “Brii Bio aims to accelerate the development and delivery of breakthrough medicines in China through partnerships,…

June 6, 2018

First US Neulasta Biosimilar Approval on Second Try for Mylan

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The FDA has approved the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim). Mylan’s Fulphila is the tenth biosimilar to be approved in the US. Mylan’s biosimilar, developed with Indian biomanufacturer Biocon, will launch Fulphilia in the coming weeks, spokesperson Julie Knell told BioProcess Insider. “Mylan is the first company to obtain approval for a biosimilar version of Neulasta in the US. Other manufacturers have sought licensure from the FDA but, to our knowledge, do not yet have approval.†She…

June 6, 2018