PDF-Biosimilars: Additional Questions and Answers Regarding Implementatio

xAttxachexd xBottxom xBBoxx 6x518x4 35x316x 96 x510x84 xSubxtypex Foxoterx Tyxpe xPagixnatixon 0xAttxachexd. Richard . Dolinar. , MD. Chairman, Alliance for Safe Biologic Medicines. Presented at the 58. th. . Consultation on. . International Nonproprietary Names . for . Pharmaceutical . Substances . Geneva, Switzerland. &#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. 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. 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. 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. 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. 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. . 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. 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 .