PPT-Biosimilar Biological Products

2016 Clinical Investigator Training Course Sue Lim MD Medical Officer OND Therapeutic Biologics and Biosimilars StaffCDERFDA November 8 2016 Overview of Presentation Biological products. 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. Introduction/Overview . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". 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. Animation: What Are Biologics?. Production of Biologics. Sources of Variation in Biologics. Variability Is a Natural and Expected Property of All Biologics. Glycosylation Affects Protein Properties. Most Biologics Have Undergone Manufacturing Changes. 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 . . Professor of Medicine. Cleveland Clinic Lerner College of Medicine . RJ . Fasenmyer. Chair of Clinical Immunology. Cleveland Clinic. Cleveland, Ohio. Edward Li, . PharmD. , MPH, BCOP . Associate Professor. 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.. & 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 . 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 . 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)) . 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. perspective. Warwick Smith. Director General BGMA & BBA. Dispensing Doctors’ Association. 20 October 2016. Stuff to cover. An introduction. Key data. Supply chain. Pricing and reimbursement. High cost generics. x0000x0000 x/Attxachexd /xBottxom x/BBoxx 3x014x333 x212x917 x322x08 3x185x63 x/Subxtypex /Foxoterx /Tyxpe /xPagixnatixon 0x/Attxachexd /xBottxom x/BBoxx 3x014x333 x212x917 x322x08 3x185x63 x/Subxtype