PPT-Building a Biosimilars Pathway in the U.S.

Author : attentionallianz | Published Date : 2020-06-23

Richard Dolinar MD Endocrinologist Chairman of the Alliance for Safe Biologic Medicines Presented at the Colorado Biosimilars Educational Forum December

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document "Building a Biosimilars Pathway in the ..." is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Building a Biosimilars Pathway in the U.S.: Transcript

Richard Dolinar MD Endocrinologist Chairman of the Alliance for Safe Biologic Medicines Presented at the Colorado Biosimilars Educational Forum December 6 2012 2 The differences between Chemical Drugs and Biotech Medicines you . Richard . Dolinar. , MD. Chairman, Alliance for Safe Biologic Medicines. Presented at the 58. th. . Consultation on. . International Nonproprietary Names . for . Pharmaceutical . Substances . Geneva, Switzerland. Presented by . the Alliance for Safe Bioloigic . Medicines & the Global Colon Cancer Association. . . . . Andrew Spiegel, Esquire. . . andrew.spiegel@globalcca.org. THANK YOU! . Knowledge Connect Slide Resource. This slide deck has been designed to be used as a central resource from which pertinent slides can be extracted as needed . and is not intended for use in its entirety. Introduction/Overview . PLANETRA Extension Study: . ACR50 Response Rate. Etanercept vs SB4 (Etanercept Biosimilar): ACR20 Response Rates. Typical Study Design for Biosimilar Switching Studies in Rheumatology. OMICS Group Biosimilars 2015 Birmingham, UK. 10-11 Aug 2015. Hazel Gorham . GorhamHazel@prahs.com. Topics. What is a Biosimilar and Why?. Demonstrating Similarity . Quality attributes. Non-clinical animal. interchangeability,extrapolation. and safety. Dr . Valderílio. . Feijó. . Azevedo. , MD, PhD. Universidade. Federal do Paraná. Edumed. Biotech. . Adjunct professor of rheumatology at the Federal University of Paraná, Brazil . . August, 2014. Biologics & Biosimilars: . An Overview. 1. What is a biologic?. 2. Biologics Are Complex. Biologics are innovative medications that aren’t made, they are grown in living cells. . Biologics are complex molecules– up to 1,000 times larger than conventional medicines. . Alice DOMINIQUE - M2 AREIPS. 1. Content. 2. Definitions. 3. What. . is. a . biological. . medicine. ?. Biological medicine = Biologic medical product . . . . = Biological . . . Kevin Olson, CEO. Industry Standard Research. KevinO@ISRreports.com. October, 2015. Table of contents. ASBM - US Prescribers and Biosimilars Naming. 2. Page. 3 . Methodology. 12. . Drug Recording Practices. By. ANSHUL . SHARMA. Graduate Research Scholar. Deptt. Of Biochemical Engg & Biotechnology,. Indian Institute of Technology, Delhi . Biosimilars. Coined by EMA (European Medicine Agency). Bio-betters. Dr Chris Deighton. Consultant Rheumatologist . Conflicts of interest. Advisory boards for . Hospira. and . Napp. Work with Pfizer, Janssen, . Abbvie. , Roche . Arguments for. We have been using . biosimilars. biosimilars. Prof. dr. Steven Simoens. Health economist. Conflict of interest. I . am one of the founders of the KU Leuven Fund on Market Analysis of Biologics and . Biosimilars. following Loss of Exclusivity (MABEL) . – what's your gut feeling?. 25th Anniversary EAHP Congress - Hospital Pharmacy 5.0 - the future of patient care . . PharmDr. . Tomas Tesar. , PhD., MBA, MPH. Disclosure. : I. declare that . Disclaimer. This panel is moderated by Dr. Delphine Courmier, Executive Director Global Head of Pricing. & Biosimilars Market Access at Organon. The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon..

Download Document

Here is the link to download the presentation.
"Building a Biosimilars Pathway in the U.S."The content belongs to its owner. You may download and print it for personal use, without modification, and keep all copyright notices. By downloading, you agree to these terms.