PPT-  What is the value of Real-World Evidence for Biosimilars?

Disclaimer This panel is moderated by Dr Delphine Courmier Executive Director Global Head of Pricing amp Biosimilars Market Access at Organon The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon. 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. How Do Real-World Data Fit In? . Program Goals. VTE Is a Leading Cause of Death Worldwide. NOACs: VTE Clinical Trials. Real-World Data. XALIA. A Prospective, Noninterventional Study. EINSTEIN-DVT and XALIA: Outcomes. Introduction/Overview . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". 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. 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. Ms. Leah Goodman. Contents. Key Messages. An Overview - Biological Medicines and their Regulatory Framework. PhAMA Position and Recommendation on Biosimilars . An Overview - Biological Medicines and their Regulatory Framework. February 15, 2017. Clinical Innovation Seminar. Mary Jo Lamberti, PhD. Senior Research Fellow. Tufts CSDD . About Tufts CSDD.                       . An . independent, academic, non-profit research group at Tufts . 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. OMIC Group. Biosimilars 2104. Hyderabad. India. 27-29 October 2014. Rodeina Challand. ChallandRodeina@prahs.com. Biologic Molecules. Biologic . molecules are complex macromolecules with some form of polymer structure. They can be purified from naturally derived substances, produced . 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 . SIG, 22.05.12. A. Gaughan. Director, Payer and RWE Informatics | AstraZeneca. A Pharma Perspective. In the Beginning...... One data customer, with predictable habits. 2. . And now...... Multiple data customers, many different tastes..... – 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 . What is RWE?. RWE, real-world evidence. .. 1. Food and Drug Administration. RWE. https. ://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence . (Accessed July 2019)..