PPT-PhAMA Position on Biosimilar Medicines

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. 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. Knowledge Connect Slide Resource. This slide deck has been designed to be used as a central resource from which pertinent slides can be extracted as needed . and is not intended for use in its entirety. 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. & 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. . August, 2014. Biologics & Biosimilars: . An Overview. 1. What is a biologic?. 2. Biologics Are Complex. Biologics are innovative medications that aren’t made, they are grown in living cells. . Biologics are complex molecules– up to 1,000 times larger than conventional medicines. . 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 . 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)) . 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 . 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. USP Global Public Policy PositionCombatting Substandard and Falsi31ied Medicines2ISSUE Substandard and falsi31ied medicines pose a major threat to global health Poor-quality medicines cause more than Basic enquiry answering. September . 2016. Session aims. Increase awareness of the Medicines Information (MI) services. UK. Wales. Increase awareness of the questions to ask an enquirer. Have practical experience using some resources which will be...