Corporate Banner
Satellite Banner
ADME Tox
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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 TechnologyNetworks.com 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
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
Bile Acid Supports Production of Blood Stem Cells
A research group at Lund University has been able to show that bile acid is transferred from the mother to the foetus via the placenta to enable the foetus to produce blood stem cells.
Chemical Used to Replace BPA is Potentially Toxic
This study is the first to examine the effects of BPA and BPS on brain cells and genes that control the growth and function of organs involved in reproduction.
A Better Model for Parkinson's
Scientists at EPFL solve a longstanding problem with modeling Parkinson’s disease in animals. Using newfound insights, they improve both cell and animal models for the disease, which can propel research and drug development.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Toxicity Testing With Cultured Liver Cells
Microreactor replaces animal testing.
Neural Networks Adapt to the Presence of a Toxic HIV Protein
HIV-associated neurocognitive disorders (HAND) afflict approximately half of HIV infected patients.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
SELECTBIO

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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!