PPT-Latin American Biologics/Biosimilars Conference

Presented by the Alliance for Safe Bioloigic Medicines amp the Global Colon Cancer Association Andrew Spiegel Esquire andrewspiegelglobalccaorg THANK YOU . Interchangeability = SubstitutabilityInterchangeable biologics must produce the same result in any given patient, and without negative effects, in terms of safety or efficacy, from switching between t 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. Animation: What Are Biologics?. Production of Biologics. Sources of Variation in Biologics. Variability Is a Natural and Expected Property of All Biologics. Glycosylation Affects Protein Properties. Most Biologics Have Undergone Manufacturing Changes. 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. . 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. 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). 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 . Dr.G.Hima. . Bindu. . MD; PG dip. . diabetology. Asst.Professor. Dept. of Pharmacology. Rajiv Gandhi Institute of Medical Sciences. Ongole. 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) . 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.. Clue: . A biologic product with no clinically meaningful differences from its reference product.  . What is… . A biosimilar. A biosimilar is a biological product that:. 1,2. . Is highly similar to the RP notwithstanding minor differences in clinically inactive components; and. What does personalisation . mean . for you?. Ian N Bruce. Kellgren. Centre for Rheumatology. NIHR . Manchester Biomedical Research . Centre University of Manchester . @. Lupusdoc. Manchester University Hospitals NHS Trust and University of Manchester.