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. 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. biosimilar. . ?. David Lim, Julie Hepworth, Lisa Nissen. c113.lim@qut.edu.au. CC-BY,NC Sarah Macmillan. Biotech . protein. Biotech . drug. Biopharmaceutical. Follow-on biologic . product < . 生. 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. View . from the Life Sciences . Industry. Moderator: Hans Sauer, Biotechnology Innovation Organization (BIO). Speakers. :. Peter . Cicala. , Celgene. Phil . Makrogiannis. , . Thermo. Fisher Scientific. Richard Montes, Ph.D.. Hospira. , a Pfizer company. Biosimilars Pharmaceutical . Sciences (Statistics). Presentation Outline. Background on demonstration . of biosimilarity. Tier . 1 . (Equivalence Testing). 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. Key Issues and Challenges.  . Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: . Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications. 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 . 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. 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. Once . the protection of the product . expires for . example, patents or regulatory protection such as data . exclusivity, . the company no longer has exclusive rights to sell the medicine. . Other .