Related Experiment Video
Updated: Jun 17, 2026

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
Published on: January 24, 2025
Biosimilar medicines--new challenges for a new class of medicine
1Regulatory Affairs CMC, Amgen, Inc., Thousand Oaks, California 91320-1799, USA. afox@amgen.com
Abstract:
Biosimilars are a new class of medicine. The European Medicines Agency has pioneered the legal, regulatory, and scientific framework for approval of these products. One of the foundational principles of the European framework is that biosimilars are expected to be similar, not identical, to the innovator biologics they seek to copy. This contrasts with the legal, regulatory, and scientific framework for copies of chemical medicines, generics, which are based on the expectation that the innovator and generic drug substance are identical. This article reviews the European biosimilar regulatory pathway and reviews some of the clinical data being made public following the approval, rejection, and withdrawal of biosimilar marketing applications.
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Bioequivalence: Overview
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Bioequivalence studies: Biowaivers

