PPT-Biosimilars and biologics –

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. Richard . Dolinar. , MD. Chairman, Alliance for Safe Biologic Medicines. Presented at the 58. th. . Consultation on. . International Nonproprietary Names . for . Pharmaceutical . Substances . Geneva, Switzerland. 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 . 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. 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. 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.. 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 . Safety (BEST) Initiative: . Pilot Year. Azadeh Shoaibi, PHD, MHS. CBER Sentinel Lead. FDA Center for Biologics Evaluation and Research. October 12, 2018. Outline. What are Biologics? . BEST Initiative: a component of the CBER Sentinel Program. 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) . 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.