PPT-1 Immunogenicity The key safety issue for biosimilars

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. Xiaoying Chen, . Timothy Hickling. , Paolo Vicini. PDM-NBE, Pfizer, USA. New technologies for immunogenicity assays/prediction. European Immunogenicity Platform February 23-25, 2015 . Complexity of Immunogenicity. 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. Introduction/Overview . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". 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 . . 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. . Alice DOMINIQUE - M2 AREIPS. 1. Content. 2. Definitions. 3. What. . is. a . biological. . medicine. ?. Biological medicine = Biologic medical product . . . . = Biological . . . 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. OMIC Group. Biosimilars 2104. Hyderabad. India. 27-29 October 2014. Rodeina Challand. ChallandRodeina@prahs.com. Biologic Molecules. Biologic . molecules are complex macromolecules with some form of polymer structure. They can be purified from naturally derived substances, produced . 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 . REFERENCE T - : Preclinical Assessment and Mitigation L.P. Cousens 1 , V. Jawa 2 , M. Awwad 3 , E. Wakshull 4 , H. Kropshofer 5 , W. Martin 1 , A.S. De Groot 1,6 1 EpiVax, Inc . USA , 2 Amgen Inc . – what's your gut feeling?. 25th Anniversary EAHP Congress - Hospital Pharmacy 5.0 - the future of patient care . . PharmDr. . Tomas Tesar. , PhD., MBA, MPH. Disclosure. : I. declare that . Biotherapeutics. Biowaivers. and . Biosimilars. – 2014. October 27-29, 2014 . Hyderabad, India. Surendra J. Chavan, Ph.D.. CTO & Founder. Quantimmune. Solutions PVT. Subsidiary of . Accutest. Disclaimer. This panel is moderated by Dr. Delphine Courmier, Executive Director Global Head of Pricing. & Biosimilars Market Access at Organon. The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon.. Clue: . A biologic product with no clinically meaningful differences from its reference product.  . What is… . A biosimilar. A biosimilar is a biological product that:. 1,2. . Is highly similar to the RP notwithstanding minor differences in clinically inactive components; and.