Biosimilars from Development to Registration

Date: Friday, 09 March 2018 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes
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The European Union (EU) currently has around a decade of experience with biosimilars. The first wave of biosimilars comprised simple biologics, such as somatropin, erythropoietin and filgrastim. The European Commission (EC) granted marketing authorization for 14 biosimilars between April 2006 and June 2010. The approval of the first monoclonal antibody (mAb) biosimilar in 2013 - Inflectra/Remsima from then Celltrion and Hospira - marked the beginning of the second wave of approvals and the first of the more complex biosimilars. Between September 2013 and March 2017, the EC granted marketing authorization for 17 biosimilars, 10 of which were in 2016 and 2017.
Biosomilar development
Instructor: Salma Michor
Product ID: 504679
The US market has however been somewhat behind Europe, due to the lack of a clear regulatory pathway prior to the Biologics Price Competition and Innovation Act (BPCIA). It was some years before the first biosimilars were able to follow it through to FDA approval, the first being Sandoz' (Novartis) Zarxio (filgrastim-sndz) in March 2015. Biosimilar developers are now making headway, and this webinar give an oversight of current Biosimilars and highlights important steps in Biosomilar development.

Why Should you Attend
The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.

This webinar give an oversight of current Biosimilars and highlights important steps in Biosomilar development. This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access, A biosimilar is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.

Areas Covered
  • Design and TPP
  • Pre-clinical Testing and Comparability
  • Clinical Testing
  • Analytical Studies
  • Stability of Biosimilar Products
Who will Benefit
  • Biosimilar/Biologic Pharmaceuticals
  • Biomedical Product Development and Manufacturing
  • Regulatory Affairs
  • Clinical and Nonclinical Research
  • Biostatistics and Data Management
  • Business Development
  • Marketing and Commercialization
  • Medical Communications/MSLs
  • Patient Advocacy/Patient Support Programs
  • Advertising and Promotion, Marketing
$250
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Instructor Profile:
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously,She worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
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