PPT-Biosimilars Guideline – a Summary of the Industry Comments

M Bredenhann Nycomed 191110 BIOSIMILARS The Scientific Aspects BIOSIMILARS Regulatory Update EU US BIOSIMILARS Summary of Industry omments on the MCC Guideline Discussion Topics. biosimilars. in Australia. David Lim, Evan Siegel, V Bruce Sunderland, Vincent Chan, Lisa Nissen. c113.lim@qut.edu.au. (C) http://www.flickr.com/photos/63436063@N05. /. Biotech proteins. Biotech drugs. Schiestl M, Stangler T, Torella C, et al. . Nat Biotechnol.. 2011;29(4):310-2.. http://www.nature.com/nbt/journal/v29/n4/full/nbt.1839.html. Trial Design and Methods. Three major, marketed glycosylated biopharmaceuticals are reviewed, analyzing quality profiles of darbepoetin alfa, rituximab, and etanercept. 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. US Prescribers and Biosimilars Naming. Kevin Olson, CEO. Industry Standard Research. KevinO@ISRreports.com. October, 2015. Table of contents. ASBM - US Prescribers and Biosimilars Naming. 2. Page. 3 . 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. 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. 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.. Kevin Olson, CEO. Industry Standard Research. KevinO@ISRreports.com. October, 2015. Table of contents. ASBM - US Prescribers and Biosimilars Naming. 2. Page. 3 . Methodology. 12. . Drug Recording Practices. By. ANSHUL . SHARMA. Graduate Research Scholar. Deptt. Of Biochemical Engg & Biotechnology,. Indian Institute of Technology, Delhi . Biosimilars. Coined by EMA (European Medicine Agency). Bio-betters. Richard . Dolinar. , MD. Endocrinologist, Chairman of the Alliance for Safe Biologic Medicines. Presented at the . Colorado . Biosimilars. . Educational Forum  . December . 6, . 2012. 2. The differences between Chemical Drugs and Biotech Medicines you . Dr.G.Hima. . Bindu. . MD; PG dip. . diabetology. Asst.Professor. Dept. of Pharmacology. Rajiv Gandhi Institute of Medical Sciences. Ongole. Prof. Ibrahim A. . Alsarra. Professor . of . Pharmaceutics . and Pharmaceutical . Biotechnology.                                  .  . Immunogenicity. : the capability of a specific substance to induce an unwanted immune response that is triggered by more than one single factor..