PDF-Biosimilars: Questions and Answers Regarding Implementation of the Bi

xAttxachexd xBottxom xBBoxx 6x518x4 35x316x 96 x510x84 xSubxtypex Foxoterx Tyxpe xPagixnatixon 0xAttxachexd. 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. Schiestl M, Stangler T, Torella C, et al. . Nat Biotechnol.. 2011;29(4):310-2.. http://www.nature.com/nbt/journal/v29/n4/full/nbt.1839.html. Trial Design and Methods. Three major, marketed glycosylated biopharmaceuticals are reviewed, analyzing quality profiles of darbepoetin alfa, rituximab, and etanercept. 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 . 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. 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. . 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 . 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. 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) . – 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..