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. 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. Katalin. . Karikó. , . PhD. BioNTech. . RNA . Pharmaceuticals. Mainz, Germany. http://www.biontech.de. katalin.kariko@biontech.de. 7. th. EIP Congress, Lisbon. February 25, . 2015. RNA therapeutics in clinical trials. Proteolytic. Susceptibility … . Fátima. Ferreira. Department of Molecular Biology. University of Salzburg, Austria. WHAT SHAPES AN ALLERGEN. ?. The. . diversity. . and. . complexity. . of. . Program Introduction . Technologies Used to Produce Therapeutic mAbs. Molecular Structures of Biologic Drugs Used to Treat Psoriasis. Biologics: Consequences of ADAs. Consequences of . ADAs. Biologics: Types of ADAs. 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. Introduction/Overview . PLANETRA Extension Study: . ACR50 Response Rate. Etanercept vs SB4 (Etanercept Biosimilar): ACR20 Response Rates. Typical Study Design for Biosimilar Switching Studies in Rheumatology. 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. . T-Cell Dependent Immunogenicity of Protein TherapeuticsPreclinical Assessment and MitigationLP Cousens1 V Jawa2 M Awwad3 E Wakshull4 H Kropshofer5 W Martin1 AS De Groot161EpiVax Inc USA2Amgen IncUSA 3 PhD MBA FAAPSLarge PharmaJanssen BioTherapeuticsGopi ShankarMS PhD MBA FAAPS isVice Presidentand Head of Biologics Development Sciences BDSwithin Janssen BioTherapeuticsJBIO Janssen Research Develop – 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 . 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..