alexa Biosimilars: Regulatory Approval Pathway
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

3rd International Conference and Exhibition on Biowaivers, Biologics & Biosimilars
October 27-29, 2014 Hyderabad International Convention Centre, Hyderabad, India

Ghayaz
Posters: J Bioanal Biomed
DOI: 10.4172/1948-593X.S1.014
Abstract
The expiration of patents for a number of blockbuster biologics, increasing pressure for lower cost versions of biological Medicines, ushered in an era of the subsequent production of biosimilar products. A biosimilar medicinal product is a biological medicine which is similar to another biological medicine that has already been authorized for use, the ?reference medicinal product? expected to have the same safety and efficacy profile. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars in order to facilitate the global harmonization. Biosimilarauthorization poses a number of substantial scientific and regulatory challenges for regulatory authorities. Committee for Medicinal Products for Human Use (CHMP) has also issued several product classspecific guidance that sets out product requirements in greater detail. The basic concepts and main principles of approving biosimilars are similar among various nations, notwithstanding some differences in regard to the scope, the choice of reference product, and the data requirement.
image PDF   |   image HTML
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords