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

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 . 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 . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". Practical Legal/Regulatory Considerations Arising In The Course Of The Pathway’s Implementation. John M. Engel, Esq.. Managing Partner. Engel & Novitt, . l. lp. The Law Firm That Knows Its Science. 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. This program will include a discussion of off-label treatments and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.. Alice DOMINIQUE - M2 AREIPS. 1. Content. 2. Definitions. 3. What. . is. a . biological. . medicine. ?. Biological medicine = Biologic medical product . . . . = Biological . . . Agenda. Key Regulatory Exclusivities for Biologics. Additional Regulatory Exclusivities. Patent Strategy for Biologics. Comparison Between the 262(k) Pathway and the ANDA Pathway. Comparison Between the 262(k) Pathway and the ANDA Pathway (continued). 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. Key Issues and Challenges.  . Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: . Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications. 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 . – 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..