Amgen's First EU Biosimilar Filing Targets AbbVie's Humira
This article was originally published in Scrip
Amgen has begun its incursion into the EU biosimilars market by filing an approval application with the European Medicines Agency for ABP 501, a version of AbbVie's blockbuster MAb Humira (adalimumab). This is the company's first biosimilar filing in Europe, and it believes it is also the first EU filing for a biosimilar Humira.
You may also be interested in...
A legislative provision under which future COVID-19 vaccines can be made available in the UK before they are approved is also being used to offer an unlicensed flu vaccine that officials say has undergone full safety, efficacy and quality tests.
With product shortages made worse by the pandemic, companies in the UK are being asked to use a new system for notifying potential supply disruptions and any plans to discontinue specific medicines.
Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.