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
Progress report on Biosimilars including World’s Largest Biologics Market - the US
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
Biosimilars are becoming established in the highly regulated markets, and, along with alternative biologics (those not developed through comparison to an existing approved biologic), are becoming common in the emerging markets. However, the US while the leading biologics market in the world is lagging with respect to biosimilars. Given that the US’s 50% of the global biologics market is being consumed by a country having only 5% of the world’s population and the US is suffering from economic pressures and demographic trends comparable to other developed countries, is this sustainable? And, especially since the growth area for medicines in development is biotechnology, including hundreds of Monoclonal antibodies (mAbs), with a total of over 900 products in clinical studies, these challenges can only increase.
In March 2010 as part of the Patient Protection and Affordable Care Act (PPACA) or “Obamacare”, substantial changes were made to the US health care system. Also, FDA was given the authority to approve biosimilars that explicitly refer to a product previously approved in the US as long as 12 years have passed since that originator product was approved. Given that FDA has led the world with the regulation and licensure of biotech products, including with the development of comparability as a scientific and regulatory concept by which manufacturing changes can be made for existing biologics.
Topics will be discussed on this webinar.
- what is the hold up?
- Why have the much promised umbrella guidance promised by the FDA not been issued?
- What does this mean for the availability of the US regulatory pathway?
- And more to the point, without FDA action, can sponsors expect to be able to make biosimilars for a global market and worldwide patient need?
- What does the FDA inaction mean for patient access in the US and well beyond?
- Does Europe continue to get further and further ahead?
Who should attend
Anyone who is involved in biosimilars, regulatory/quality, drug development etc.
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.