Other related webinars
Essential Biosimilars Perspectives for Indian Ph...
Monday, 29th November, 2010
Time : 02:00 PM IST | 09:30 AM CET
Essential Biosimilars Perspectives for American ...
Thursday, 10th February, 2011
Time : 02:00 PM EST | 11:00 AM PST
Vital Perspectives on Monoclonal Antibody (mAB) ...
Monday, 18th April, 2011
Time : 02:00 PM | 11:00 AM
Essential Regulatory Perspectives and Best Clini...
Thursday, 15th September, 2011
Time : 02:00 PM IST | 09:30 AM CET
The strategic importance and key success factors...
Friday, 4th November, 2011
Time : 02:00 PM | 11:00 AM
Unwanted Immunogenicity of Biosimilars or follow...
Friday, 18th November, 2011
Time : 02:00 PM | 11:00 AM
A Glimpse of the Future - US Biosimilars Litigat...
Thursday, 15th December, 2011
Time : 02:00 PM | 11:00 AM
European approval of Biosimilar products – wha...
Thursday, 22nd December, 2011
Time : 02:00 PM EST | 11:00 AM PST
Progress report on Biosimilars including World...
Friday, 17th February, 2012
Time : 02:00 PM EST | 11:00 AM PST
Interpretation & insight into the FDA draft guid...
Friday, 2nd March, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA’s Current Thinking on Regulatory Path of B...
Friday, 16th March, 2012
Time : 02:00 PM EST | 11:00 AM PST
Comparing and contrasting FDA BIOSIMILARS guidan...
Friday, 27th April, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of the newly released final 2012 EU ...
Wednesday, 25th July, 2012
Time : 02:00 PM EST | 11:00 AM PST
A EU/US Regulatory and Technical Practical Persp...
Friday, 31st August, 2012
Time : 02:00 PM EST | 11:00 AM PST
Assessing the Global Biosimilar Market
Friday, 5th October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Harmonization in Biosimilars: EU and FDA Accepta...
Tuesday, 23rd October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Scientific and Regulatory Issues in the Demonstr...
Friday, 14th December, 2012
Time : 02:00 PM EST | 11:00 AM PST
Biologics in a World with Biosimilars
Wednesday, 26th June, 2013
Time : 02:00 PM EST | 11:00 AM PST
Exploring latest FDA/EMA concepts of US-EU compa...
Friday, 15th November, 2013
Time : 02:00 PM EST | 11:00 AM PST
Executive Update of the US/EU status and opportu...
Wednesday, 27th May, 2015
Time : 02:00 PM EST | 11:00 AM PST
Biosimilar Orphan Drugs: The Next Regulatory Cha...
Friday, 21st October, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Unique executive perspectives into biologics and...
Friday, 25th November, 2016
Time : 02:00 PM IST | 09:30 AM BST
Biosimilars: Key factors for successful uptake i...
Friday, 3rd February, 2017
Time : 01:00 PM EST | 10:00 AM PST
Biosimilars Advances in the Approvals of Biosimi...
Thursday, 7th September, 2017
Time : 01:00 PM EST | 10:00 AM PST
FDA - Important Aspects to Consider When Determi...
Friday, 20th October, 2017
Time : 01:00 PM EST | 10:30 AM PST
Pitfalls in the Analytical Characterization of B...
Friday, 22nd December, 2017
Time : 01:00 PM EST | 10:30 AM PST
Understanding Bioavailability And Bioequivalence...
Wednesday, 28th March, 2018
Time : 01:00 PM EST | 11:30 AM BST
FDA Interchangeability Requirements for Biosimil...
Thursday, 19th April, 2018
Time : 01:00 PM EST | 10:00 AM PST
Executive insights into the FDA "Purple Book" Cl...
Friday, 17th July, 2020
Time : 01:00 PM EST | 11:30 AM BST
Evaluating the pathway for registration of Biosi...
Friday, 23rd September, 2022
Time : 01:00 PM EST | 10:00 AM PST
Recorded Webinar
Biosimilar Orphan Drugs: The Next Regulatory Challenge
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Global orphan drugs market is expected to reach $176 billion mark by the end of 2020 (Report August 2016). A 10.5% compound annual growth rate will see the prescription sales in the orphan sector grow at twice the rate of the overall prescription market which is set to grow at just 5.3% annually between 2014 and 2020. This growth is partially due to the high number of biological orphan drugs, which are currently less susceptible to generic (biosimilar) erosion as compared to small molecules. Meaning, their high economic value continues beyond the end of patent expiration. While an orphan drug would appear, at first glance, to be an attractive candidate for biosimilar drug development there are a number of significant challenges that may deter some developers from undertaking such product development programmes. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have guidance for orphan drug development. However, there are no specific guidance for the development of a biosimilar orphan drug. If we are to apply the overarching biosimilar guidances’ in place for a biosimilar orphan drug development, the challenges are enormous and could hinder the development of such drugs.
This presentation aims to address some of the challenges and to encourage debate in the wider community
- Regulatory Pathway
- Historical data
- Effect size
- Sample size
- Recruitment
- Comparator sourcing and cost
Content Disclaimer
Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.