PPT-Challenges in demonstrating biosimilarity and interchangeability of biosimilar products

Author : calandra-battersby | Published Date : 2018-10-12

OMICS Group Biosimilars 2015 Birmingham UK 1011 Aug 2015 Hazel Gorham GorhamHazelprahscom Topics What is a Biosimilar and Why Demonstrating Similarity Quality

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Challenges in demonstrating biosimilarity and interchangeability of biosimilar products: Transcript

OMICS Group Biosimilars 2015 Birmingham UK 1011 Aug 2015 Hazel Gorham GorhamHazelprahscom Topics What is a Biosimilar and Why Demonstrating Similarity Quality attributes Nonclinical animal. 574115745557453574535744557454574605745957376574415745457444573765745957461574475744757445574595746057449574555745457459573765745857445574475744157458574445744957454574475737657460574485744957459573765744457458574415744657460573765744457455574435746 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. Richard Montes, Ph.D.. Hospira. , a Pfizer company. Biosimilars Pharmaceutical . Sciences (Statistics). Presentation Outline. Background on demonstration . of biosimilarity. Tier . 1 . (Equivalence Testing). & 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. . 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. 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)) . 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. 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. 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.

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