PPT-MODULE 8. Follow-on drugs: generic, biosimilar

amp nonbiological similar medicinal products Cooperative European Medicines Development Course CEMDC 14 Appreciate the factors influencing the adoption of followon drugs in the everyday practice . 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. 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. Introduction/Overview . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". View . from the Life Sciences . Industry. Moderator: Hans Sauer, Biotechnology Innovation Organization (BIO). Speakers. :. Peter . Cicala. , Celgene. Phil . Makrogiannis. , . Thermo. Fisher Scientific. 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. OMICS Group Biosimilars 2015 Birmingham, UK. 10-11 Aug 2015. Hazel Gorham . GorhamHazel@prahs.com. Topics. What is a Biosimilar and Why?. Demonstrating Similarity . Quality attributes. Non-clinical animal. 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. 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. 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. 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 . 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. Generic. . drugs. It’s. . possible. to produce . generic. . drugs. . once the period of ‘exclusivity’ on the reference medicine has expired . . Tipically. . 10 . years. . from the date of .