chevron_left Categories

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

Evaluating the pathway for registration of Biosi...

Friday, 2nd December, 2016
Time : 11:00 AM IST | 06:30 AM BST

Executive insights into the FDA "Purple Book" Cl...

Monday, 19th December, 2016
Time : 04:00 PM IST | 11:30 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

Recorded Webinar

FDA - Important Aspects to Consider When Determining Interchangeability

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

On January 17, 2017, FDA released the long-awaited draft Guidance for Industry to help firms understand the considerations FDA deems necessary to prove interchangeability between an approved reference product and a proposed, less-expensive biologic.

Obviously, it’s critical for industry to understand the points addressed in this new guidance:

  • What does FDA expect from manufacturers who feel they have a product which can be approved as interchangeable under the BPCI Act?
  • What are the differences between biosimilar and interchangeable biologics?
  • What studies are needed to demonstrate biosimilarity?

Key Areas Covered During the Webinar:
  • Understand key definitions
  • How to demonstrate interchangeability?
  • Why immunogenicity is important to consider for interchangeable products?
  • What are the factors affecting immunogenicity and how to mitigate the risks.
  • How to design studies required to demonstrate interchangeability?


Apply for this webinar

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.

//