PPT-The generic and biosimilar

perspective Warwick Smith Director General BGMA amp BBA Dispensing Doctors Association 20 October 2016 Stuff to cover An introduction Key data Supply chain Pricing and reimbursement High cost generics. Biosimilars. : Products, Recent Deals, IP Issues and Licensing. August 2, 2012. Madison C. Jellins. 1. Biologics Price Competition and Innovation Act. Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) signed into law March 2010. 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. 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. 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. Richard Montes, Ph.D.. Hospira. , a Pfizer company. Biosimilars Pharmaceutical . Sciences (Statistics). Presentation Outline. Background on demonstration . of biosimilarity. Tier . 1 . (Equivalence Testing). 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 . . & 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 . 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. Key Issues and Challenges.  . Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: . Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications. 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 .