25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. 

This was evident in the announcement this week by Alvotech, of Reykjavik, Iceland, that the FDA was deferring action on its biosimilar application for AVT02, an adalimumab candidate, because it could not conduct the necessary site inspections needed to ensure compliance with US standards for drug manufacturing.

Read Center for Biosimilars article