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. S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER April 2015 Biosimilarity brPage 2br Quality Considerations in Demonstrating Biosimi ) . and hypokineses.. Cardiac MRI demonstrating LV ejection fraction 49%(57-77), RV ejection fraction 31% (47-67%. ) . and . hypokineses. .. Cardiac MRI demonstrating LV ejection fraction 49%(57-77), RV ejection fraction 31% (47-67%. Shant. . Karakashian. Robert J. Woodward. Berthe. Y. . Choueiry. Steven D. . Prestwich. . Eugene C. Freuder. Acknowledgments. : This work was supported in part by Science Foundation Ireland under Grant 00/PI.1/C075. &#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. OMIC Group Biosimilars 2014. Hyderabad India. 27-29 Oct 2014. Rodeina Challand. ChallandRodeina@prahs.com. Global Biosimilar Concept. Generic approach is not appropriate. Step-wise comparability approach. interchangeability,extrapolation. and safety. Dr . Valderílio. . Feijó. . Azevedo. , MD, PhD. Universidade. Federal do Paraná. Edumed. Biotech. . Adjunct professor of rheumatology at the Federal University of Paraná, Brazil . . 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.. Guidelines. Kamali Chance, MPH, PhD, RAC. Senior Director . Head, Global . Biosimilars. Regulatory Strategy. Definition of . Biosimilarity. Biosimilar Guidelines Issuance in the EU and US. Regulation . 2016 . Clinical Investigator . Training Course. Sue Lim, M.D.. Medical Officer. OND Therapeutic Biologics and . Biosimilars. . Staff/CDER/FDA. November . 8. , 2016. Overview of Presentation. Biological products. Guidelines. Kamali Chance, MPH, PhD, RAC. Senior Director . Head, Global . Biosimilars. Regulatory Strategy. Definition of . Biosimilarity. Biosimilar Guidelines Issuance in the EU and US. Regulation . Guidelines. Kamali Chance, MPH, PhD, RAC. Senior Director . Head, Global . Biosimilars. Regulatory Strategy. Definition of . Biosimilarity. Biosimilar Guidelines Issuance in the EU and US. Regulation . Moffitt Cancer Center, Director of Pharmacy (Retired). Biosimilar Drugs: . Opportunities and Issues. The Community Oncology Alliance Conference. Moving Forward on Payment Reform. April 23, 2015. Disclosures.