EMA Invites Comments on Draft Revised Guideline on Biosimilars
News May 10, 2013
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.
Researchers Develop New Method to Generate Human AntibodiesNews
Researchers hope their approach will help researchers rapidly generate therapeutic antibodies for the treatment of infectious diseases and other conditions such as cancer.READ MORE
Large-Scale Production of Living Brain Cells Enables Entirely New ResearchNews
After performing a biopsy on the patient, the skin cells are transformed into brain cells that effectively imitate the disease and the age of the patient.READ MORE
U.S. Study of Dapivirine Ring in Lactating Women Finds Little Drug Gets Into Breast MilkNews
The antiretroviral drug dapivirine that is released from an experimental vaginal ring to protect against HIV is absorbed in very low concentrations into breastmilk.READ MORE
Comments | 0 ADD COMMENT
EMBL Conference: European Conference of Life Science Funders and Foundations
Apr 19 - Apr 20, 2018
EMBL Course: Target Engagement in Biology and Drug Discovery
Feb 19 - Feb 23, 2018