RAPS

EMA Announces Approval of First Two Biosimilar Monoclonal Antibodies

In a major milestone, the European Medicines Agency (EMA) has announced the approval of the first two biosimilar monoclonal antibodies in the EU, Celltrion Healthcare's Remsima and Hospira's Inflectra ...
JD Supra

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

Aydin Harston Ph.D., Alexander Shaver Ph.D. FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.
RAPS

New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies

The European Medicines Agency (EMA) has just published a new biosimilars draft guideline for consultation that outlines the general principles that industry must take into account when developing an ...
The American Journal of Managed Care

EMA and WHO "Tailor" the Biosimilar Development Process

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development ...