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

xAttxachexd xBottxom xBBoxx 6x518x4 35x316x 96 x510x84 xSubxtypex Foxoterx Tyxpe xPagixnatixon 0xAttxachexd. &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.18; 35;&#x.316;&#x 96 ;Q.0;„ ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati;&#xon 0;&#x/Att;¬he; &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.18; 35;&#x.316;&#x 96 ;Q.0;„ ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati;&#xon 0;&#x/Att;¬he; &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.18; 35;&#x.316;&#x 96 ;Q.0;„ ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati;&#xon 0;&#x/Att;¬he; 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. 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". 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.. 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 . 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. – 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 .