EU approves first biosimilar monoclonal antibody
This article was originally published in SRA
Celltrion/Hospira's own version of J&J/Merck & Co's Remicade, Inflectra (infliximab) has become the first biosimilar monoclonal antibody to win approval in the EU after the European Commission gave the drug the formal green light1. The approval marks a new era for biosimilars in Europe.
You may also be interested in...
In addition to agreeing to emergency use of the Oxford University/Astra Zeneca and Sinovac vaccines, Brazil's medicines regulator has also published good manufacturing practices certificates for Pfizer and Janssen vaccine. It has questions about the Sputnik V authorization request.
A Dutch parallel registration and reimbursement pilot has brought benefits including more participation from healthcare professionals, and also forces company divisions to be less streamlined.
The UK’s withdrawal from the EU could upset the Unitary Patent Court project.