PPT-Comparison of US/EU Biosimilar

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 . 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. 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. 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. 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 . . 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. . 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 . 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. Adoption by CHMP for release for consultation24 May 2012Start of public consultation31 May 2012End of consultation deadline for comments30 November 2012Revised draft agreed by BMWP and BWPApril 2014Ad