PPT-Challenges in demonstrating biosimilarity and interchangeability of biosimilar products

OMIC Group Biosimilars 2014 Hyderabad India 2729 Oct 2014 Rodeina Challand ChallandRodeinaprahscom Global Biosimilar Concept Generic approach is not appropriate Stepwise comparability approach. Interchangeability: Basics . . Robert. Beyond . simple . CSPs. Relating & Comparing Interchangeability . Shant. Compacting the Search Space. AND. /OR graphs, SLDD, OBDD, . The What, When and How. Alan Hume, BSc MSc. Pickering Interfaces. April 2013. References. References to NI in this document refer to National Instrument Corporation.. MAX is an abbreviation for Measurement and Automation Explorer, an NI product.. &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.18; 21;&#x.036;&#x 96 ;6.8; ];&#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. RPh. Safe School Meds, Principle Partner. Moffitt Cancer Center, Director of Pharmacy (Retired). Biosimilar Drugs: . Opportunities and Issues. The Community Oncology Alliance Conference. Moving Forward on Payment Reform. Conferences. Conference Series LLC . is a pioneer and leading science event organizer, which publishes around 500 open access journals and conducts over 500 Medical, Clinical, Engineering, Life Sciences, Pharma scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit.. 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. Richard Montes, Ph.D.. Hospira. , a Pfizer company. Biosimilars Pharmaceutical . Sciences (Statistics). Presentation Outline. Background on demonstration . of biosimilarity. Tier . 1 . (Equivalence Testing). Conference Series LLC . is a pioneer and leading science event organizer, which publishes around 500 open access journals and conducts over 500 Medical, Clinical, Engineering, Life Sciences, Pharma scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit.. & non-biological similar medicinal products . Cooperative European Medicines Development Course (CEMDC). 14. Appreciate the factors influencing the . adoption. . of follow-on drugs . in the everyday practice. . Ms. Leah Goodman. Contents. Key Messages. An Overview - Biological Medicines and their Regulatory Framework. PhAMA Position and Recommendation on Biosimilars . An Overview - Biological Medicines and their Regulatory Framework. Disclaimers. :. By 2016, 7 of the top 10 pharmaceuticals. worldwide will be biologics. ¹. Biosimilar Regulation – Around the World. U.S. Biosimilar Applications. under the BPCIA (42 U.S.C. § . 262(k)) . Adoption by CHMP for release for consultation24 May 2012Start of public consultation31 May 2012End of consultation deadline for comments30 November 2012Revised draft agreed by BMWP and BWPApril 2014Ad Sept 16, 2015. W. Heath Rushing, . Adsurgo. LLC. Andrew . Karl, . Adsurgo. LLC. Richard Burdick, Elion Labs. Outline. 2. Introduction. Current. FDA Thinking/Approach. Demonstration:. . Statistical Equivalence using Sample Size and Variance Adjustment Method.