PPT-U.S. Biosimilars: An Introduction

Disclaimers By 2016 7 of the top 10 pharmaceuticals worldwide will be biologics ¹ Biosimilar Regulation Around the World US Biosimilar Applications under the BPCIA 42 USC 262k . Richard . Dolinar. , MD. Chairman, Alliance for Safe Biologic Medicines. Presented at the 58. th. . Consultation on. . International Nonproprietary Names . for . Pharmaceutical . Substances . Geneva, Switzerland. biosimilars. in Australia. David Lim, Evan Siegel, V Bruce Sunderland, Vincent Chan, Lisa Nissen. c113.lim@qut.edu.au. (C) http://www.flickr.com/photos/63436063@N05. /. Biotech proteins. Biotech drugs. Presented by . the Alliance for Safe Bioloigic . Medicines & the Global Colon Cancer Association. . . . . Andrew Spiegel, Esquire. . . andrew.spiegel@globalcca.org. THANK YOU! . US Prescribers and Biosimilars Naming. Kevin Olson, CEO. Industry Standard Research. KevinO@ISRreports.com. October, 2015. Table of contents. ASBM - US Prescribers and Biosimilars Naming. 2. Page. 3 . 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. 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. 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 . . . Presented at the . Latin American Biologics/Biosimilars Conference. Sao Paulo, Brazil. September 27, 2016. Harry L. Gewanter, MD, FAAP, FACR . Chairman, Alliance for Safe Biologic Medicines (ASBM). 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 . Prof. Ibrahim A. . Alsarra. Professor . of . Pharmaceutics . and Pharmaceutical . Biotechnology.                                  .  . Immunogenicity. : the capability of a specific substance to induce an unwanted immune response that is triggered by more than one single factor.. 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..