Biosimilars and the FDA Guidance Documents – a discussion at Personalized Medicine TV

Biosimilars and the FDA Guidance Documents – a discussion at Personalized Medicine TV – Video

Posted: March 1, 2012 at 10:51 am

|

Video Link: https://www.youtube.com/watch?v=0sdM5ckMDso

24-02-2012 18:53 In February 2012, the FDA published 3 Guidance documents for biosimilars. Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already-approved biological product. George Dranitsaris discusses the market and challenges of biosimilars.

Read the rest here:
Biosimilars and the FDA Guidance Documents - a discussion at Personalized Medicine TV - Video

Related Posts

Personalized Medicine [Last Updated On: May 13th, 2011] [Originally Added On: May 13th, 2011]
Why Personalized Medicine...? [Last Updated On: May 13th, 2011] [Originally Added On: May 13th, 2011]
Genomics and Personalized Medicine [Last Updated On: May 13th, 2011] [Originally Added On: May 13th, 2011]
Personalized Medicine and the Future of Health Care [Last Updated On: May 17th, 2011] [Originally Added On: May 17th, 2011]
What Is Personalized Medicine? [Last Updated On: May 20th, 2011] [Originally Added On: May 20th, 2011]
Effectively Treat Autism With Personalized Medicine by Dr. David Davis, MD [Last Updated On: May 23rd, 2011] [Originally Added On: May 23rd, 2011]
Personalized Medicine In An Era of Evidence Based Medicine [Last Updated On: May 24th, 2011] [Originally Added On: May 24th, 2011]
On the Same Page: Personalized Medicine [Last Updated On: May 24th, 2011] [Originally Added On: May 24th, 2011]
Personalized Medicine (Abbott Labs) [Last Updated On: May 24th, 2011] [Originally Added On: May 24th, 2011]
Personalized Medicine - Gregory Stock at WorldFuture 2007 [Last Updated On: May 30th, 2011] [Originally Added On: May 30th, 2011]
Integrated Diagnostics and Personalized Medicine in Oncology (Part 16 of 16) [Last Updated On: May 31st, 2011] [Originally Added On: May 31st, 2011]
Personalized Medicine Keynote - Dr Ron Sokol, Director CCTSI - Part 2 [Last Updated On: June 3rd, 2011] [Originally Added On: June 3rd, 2011]
Personalized Medicine Keynote - Dr Ron Sokol, Director CCTSI - Part 3 [Last Updated On: June 3rd, 2011] [Originally Added On: June 3rd, 2011]
Personalized Medicine - David Brunel, CEO, Biodesix - Part 2 [Last Updated On: June 3rd, 2011] [Originally Added On: June 3rd, 2011]
Personalized Medicine Panel Discussion - Part 1 [Last Updated On: June 6th, 2011] [Originally Added On: June 6th, 2011]
Information-Based Personalized Medicine [Last Updated On: June 7th, 2011] [Originally Added On: June 7th, 2011]
Personalized Medicine Project [Last Updated On: June 7th, 2011] [Originally Added On: June 7th, 2011]
Personalized Medicine P4 [Last Updated On: June 9th, 2011] [Originally Added On: June 9th, 2011]
Are Personalized Medicine and System-based Care at Odds? [Last Updated On: June 10th, 2011] [Originally Added On: June 10th, 2011]
Personalized Medicine - David Brunel, CEO, Biodesix - Part 1 [Last Updated On: June 16th, 2011] [Originally Added On: June 16th, 2011]
Personalized Medicine - Fred Mitchell, CEO, Beacon Biotechnology - Part 1 [Last Updated On: June 18th, 2011] [Originally Added On: June 18th, 2011]
Personalized Medicine Keynote - Dr Ron Sokol, Director CCTSI - Part 4 [Last Updated On: June 21st, 2011] [Originally Added On: June 21st, 2011]
Personalized medicine: The future of healthcare [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
Personalized Medicine Panel Discussion - Part 2 [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
Emerging trends in medical research: Personalized medicine [Last Updated On: July 4th, 2011] [Originally Added On: July 4th, 2011]
Personalized Medicine; Stem Cells 1/2 [Last Updated On: July 5th, 2011] [Originally Added On: July 5th, 2011]
Dr. Rochelle Long on pharmacogenomics and personalized medicine [Last Updated On: July 9th, 2011] [Originally Added On: July 9th, 2011]
Kristine Martin Anderson Discusses Healthcare Reform and Personalized Medicine [Last Updated On: July 11th, 2011] [Originally Added On: July 11th, 2011]
Personalized Medicine Keynote - Dr Ron Sokol, Director CCTSI - Part 1 [Last Updated On: July 13th, 2011] [Originally Added On: July 13th, 2011]
Personalized Medicine: Genomes 1/2 [Last Updated On: July 18th, 2011] [Originally Added On: July 18th, 2011]
Dr. Tsimberidou on the Personalized Medicine Study Results [Last Updated On: July 22nd, 2011] [Originally Added On: July 22nd, 2011]
DNA Trap Advances Personalized Medicine [Last Updated On: July 24th, 2011] [Originally Added On: July 24th, 2011]
Health Matters: Personalized Medicine and Drug Safety [Last Updated On: July 25th, 2011] [Originally Added On: July 25th, 2011]
Sonali Smith, MD: Personalized Medicine and Cancer Research at ASCO 2011 [Last Updated On: July 25th, 2011] [Originally Added On: July 25th, 2011]
The Language of Life: DNA and the Revolution in Personalized Medicine [Last Updated On: August 1st, 2011] [Originally Added On: August 1st, 2011]
Personalized Medicine: Stem Cells 2/2 [Last Updated On: August 2nd, 2011] [Originally Added On: August 2nd, 2011]
Michel Sadelain, MD, PhD: What is Personalized Medicine? [Last Updated On: August 12th, 2011] [Originally Added On: August 12th, 2011]
Synthetic Biology and Data-Driven Synthetic Biology for Personalized Medicine and Clean Energy [Last Updated On: August 24th, 2011] [Originally Added On: August 24th, 2011]
Personalized Medicine: What Patients Have to Say to Industry [Last Updated On: August 29th, 2011] [Originally Added On: August 29th, 2011]
Promises and challenges of personalized medicine [Last Updated On: August 29th, 2011] [Originally Added On: August 29th, 2011]
A personalized medicine odyssey - IBA 2020 [Last Updated On: September 17th, 2011] [Originally Added On: September 17th, 2011]
Pieter Postmus, MD, PhD: Towards Personalized Medicine [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
Personalized Medicine (Pharmacogenomics) [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
How Personalized Medicine Will Transform Healthcare [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
Bill Nelson -- The Future of Personalized Cancer Medicine [Last Updated On: September 28th, 2011] [Originally Added On: September 28th, 2011]
Personalized Medicine Symposium 2011 [Last Updated On: September 29th, 2011] [Originally Added On: September 29th, 2011]
The Promise of Personalized Medicine [Last Updated On: October 3rd, 2011] [Originally Added On: October 3rd, 2011]
Stanford Hospital's Sean David, MD, on Personalized Medicine [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
The Greatest Drug In The World [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
Genes, Ancestry, and Personalized Medicine with Dr. Michael Kane - Interview Part 1.mp4 [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
Honored Gerry James Lecture: Is sarcoidosis ready for personalized medicine? [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
Dr. Mills Discusses Shifts Towards Personalized Medicine [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
Breast Cancer and Personalized Medicine [Last Updated On: October 10th, 2011] [Originally Added On: October 10th, 2011]
Personalized Medicine - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
Webinar: The New Face of Personalized Medicine - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
OHSU Knight Cancer Institute: We personalize medicine (60 seconds) - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
Innovation: Genomics and Personalized Medicine - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
Vineyard Personalized Medicine - Lisa Nagy, MD - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
Synthetic Biology and Data-Driven Synthetic Biology for Personalized Medicine and Clean Energy - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
Lawrence Brody: Genetics [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
MyAR TV: Bill Bradley, MD on Personalized Medicine - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
Personalized Medicine - Fred Mitchell, CEO, Beacon Biotechnology - Part 2 - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
Dendritic Cells and Personalized Medicine - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
BioBytes 104 - What is personalized medicine? - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
Dendritic Cells and Personalized Medicine - the fight against cancer gets personal - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
Money and Personalized Medicine: Partnering - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
Personalized Medicine and Diagnostics.mp4 - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
Keith Kerr, MD: Biomarkers and Personalized Medicine in Lung Cancer - Video [Last Updated On: November 1st, 2011] [Originally Added On: November 1st, 2011]
Dr. Goy Explains the Concept of Personalized Medicine - Video [Last Updated On: November 6th, 2011] [Originally Added On: November 6th, 2011]
Personalized Medicine and Cancer: Part 1 of 3 - Video [Last Updated On: November 10th, 2011] [Originally Added On: November 10th, 2011]
Panel - Infrastructure to Enable Personalized Medicine - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
Human Security Thesis, personalized medicine, pharmacogenomics, Pharmacogenomics - Introduction - Video [Last Updated On: November 14th, 2011] [Originally Added On: November 14th, 2011]
Venture Investment and Personalized Medicine - Video [Last Updated On: November 15th, 2011] [Originally Added On: November 15th, 2011]
Personalized Medicine: From Promise to Practice - Video [Last Updated On: November 15th, 2011] [Originally Added On: November 15th, 2011]
Paradigm Shift in Personalized Medicine with 30sec News Promo_Russ Scala - Video [Last Updated On: November 17th, 2011] [Originally Added On: November 17th, 2011]
Personalized Medicine Coalition President Ed Abraham - Video [Last Updated On: November 18th, 2011] [Originally Added On: November 18th, 2011]
Personalized Medicine World Conference 2012 discussion with Dr. Laurence Marton - Video [Last Updated On: November 18th, 2011] [Originally Added On: November 18th, 2011]
Individualized Molecular Testing for Personalized Medicine - Video [Last Updated On: November 21st, 2011] [Originally Added On: November 21st, 2011]
Nanobiosym Chairman and CEO Speaks on Future of Personalized Medicine - Video [Last Updated On: November 24th, 2011] [Originally Added On: November 24th, 2011]
From Biological Discovery and Personalized Medicine: The Role of Computation in Human Genetics - Video [Last Updated On: November 28th, 2011] [Originally Added On: November 28th, 2011]

Comments are closed.