Agency
EMA
7 published works
Big Molecule Watch
Teva Receives FDA Approval of Denosumab Biosimilar and Filing Acceptances by FDA and EMA For Omalizumab Biosimilar
On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI (denosumab-adet). PONLIMSI has been approved for…
Biosimilars Law Bulletin
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025
By Alex Shaver, Aydin H. Harston
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025. Biosimilars, once a niche segment in…
Focus on Regulation
The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations
By Elisabethann Wright, Alexander Wenzel
Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the…
BioSlice Blog
New EudraVigilance System – Updated Q&As
The new EudraVigilance drug safety monitoring system has now been up and running for nearly 5 months, and the EMA has recently published an updated Q&A, featuring questions submitted by users,…
BioSlice Blog
New NTA published
At the end of December, a new version of Chapter 1 of Volume 2A of the Notice to Applicants was published by the Commission. The Notice to Applicants is prepared…
BioSlice Blog
EudraVigilance—safety signals pilot scheme
Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the European Medicines Agency (EMA)…
Biosimilars Law Blog
Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs
By David Fox, George O'Brien, Marie A. Vodicka
Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. Authorization of Remsima represents…