PPT-Latin American Physician Perspectives on Biosimilars

Presented at the Latin American BiologicsBiosimilars Conference Sao Paulo Brazil September 27 2016 Harry L Gewanter MD FAAP FACR Chairman Alliance for Safe Biologic Medicines ASBM. 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. James C. Shehan. Hyman, Phelps & McNamara, P.C.. 700 Thirteenth Street, N.W., Suite 1200. Washington, D.C. 20005, U.S.A.. 202-737-9634 .  . jshehan@hpm.com. October 29, 2014. Agenda. BPCIA Overview. 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". 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 . . 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.. 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 . . . Open Access publications.  and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 400 online open access . 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 . 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 .