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
Biosimilars Advances in the Approvals of Biosimilars by The FDA Since Only in 4th Q 2015, and a Decade 2006-2017 of Approvals by the EMA
timelapse 60 Min with 15 Min QnA 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
The FDA have required bridging pharmacokinetic bioequivalence studies. Impressive is the FDA tackling monoclonal antibodies under abbreviated BLA’s before gaining more experience with simpler molecules, whereas in Europe these heterogeneous molecules were only submitted under MAA’s only after 6 years of first EU biosimilar approvals in 2006. However, the FDA were not able to approve peglyated filgrastim leading to withdrawal of the ABLA.
Meanwhile, after the EMA’s 10th year anniversary of biosimilar approvals, EMA have continued to approve representatives of new classes of biosimilars for haemolytic disorders and osteoporosis. Others, such as the first 2 oncology biosimilar mAbs, the first in a most difficult class of products, are under recent approval or assessment by the EMA, filed by a pioneering sponsor in the mAb field.
Finally, FDA have published their long awaited interchangeability guidance in February, with huge implications.
This presentation aims to address some of the challenges and to encourage debate in the wider community
- FDA draft guidance Jan 2017 Demonstrating Interchangeability
- Insulin glargine Basaglar US submission
- Comparing approved labels of biosimilar Zarxio ABLA 351k with Granix BLA 351a pathways (USA)
- Navigating an optimal biosimilars development? Overcoming foreseeable barriers to approval?
- Biosimilar Development US Pipeline
- US approved biosimilars
- Clinical safety of biologic comparatively Risk
- FDA conditions for biosimilar interchangeable with reference (originator) product (RP), 2012 to 2016
- Interchangeability, the 5th hurdle? Design?Our proposals in 2015
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.