Fda

Image: iStock/EikoTsuttiy

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

By Dan Stanton

Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.

Sandoz' Bioinject facility in Austria. One of several sites that could make biosimilar pegfilgrastim for the US

Update: Sandoz remains committed to launching 5 biosims by 2020

US FDA rejects Sandoz’s Neulasta biosimilar

By Gareth Macdonald

The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.