Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

EMA Invites Comments on Draft Revised Guideline on Biosimilars

Published: Friday, May 10, 2013
Last Updated: Friday, May 10, 2013
Bookmark and Share
EMA has revised its overarching guideline on similar biological medicines and published a draft for public consultation.

This document describes the concept of similar biological medicines (also known as ‘biosimilars’) and outlines the general principles to be applied.

The publication of the initial guideline on biosimilars in September 2005 established a regulatory framework that has led to the approval of 14 biosimilars in the European Union (EU) to date. Five applications for biosimilars are currently under review.

On the basis of the experience gained since the release of the initial guideline, the revision intends to:
•    provide clarification with regards to terminology for biosimilars;
•    give better clarity on the principles of biosimilarity, including on safety and efficacy aspects;
•    clarify requirements regarding the posology, route of administration and formulation of biosimilars.

The revision also covers global development aspects, including the choice of the reference product when conducting non-clinical and clinical studies.

In order to get a marketing authorisation in the EU, developers of biosimilars need to conduct comparability studies to show the similar nature, in terms of quality, safety and efficacy, of the biosimilar and the chosen reference medicinal product authorised in the European Economic Area (EEA).

With the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, the guideline explains that it may be possible for an applicant to compare its biosimilar in certain clinical studies and in vivo non-clinical studies with a comparator authorised outside of the EEA. This comparator will need to be authorised by a regulatory authority with similar scientific and regulatory standards to those of the EMA. It will then be the applicant's responsibility to establish that the comparator is representative of the reference product authorised in the EEA.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,100+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
Integrated Omics Analysis
Studying multi-omics promises to give a more holistic picture of the organism and its place in its ecosystem, however despite the complexities involved those within the field are optimistic.
Unravelling the Role of Key Genes and DNA Methylation in Blood Cell Malignancies
Researchers from the University of Nebraska Medical Center have demonstrated the role of Dnmt3a in safeguarding normal haematopoiesis.
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
Structure of Primary Cannabinoid Receptor is Revealed
The findings provide key insights into how natural and synthetic cannabinoids including tetrahydrocannabinol —a primary chemical in marijuana—bind at the CB1 receptor to produce their effects.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Illumina Contributes to ClinVar Database
The contribution includes variants of all classifications, from pathogenic to benign, identified during interpretation of whole genome sequences generated in the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory.
Agilent Presents Early Career Professor Award to Dr. Roeland Verhaak
JAX professor recognized for the development and implementation of workflows for the analysis of big-data from transcriptomics to next generation sequencing approaches.
NIH Study Determines Key Differences between Allergic and Non-Allergic Dust Mite Proteins
Researchers at NIH have uncovered factors that lead to the development of dust mite allergy and assist in the design of better allergy therapies.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,100+ scientific videos