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Session 8B: The Use of Biosimilars in the Middle East: Is it a Vice or a Virtue? (Parallel Session 2)
Session Chair(s)
Virginia Acha, PHD, MSC
Global Lead, Global Regulatory Policy, Merck & Co., Inc., United States
The biosimilar use is still considered a new encounter in the Middle Eastern areas. Despite the recent adoption of the FDA & EMA guidance, many countries don’t have any experience with their use, with very little published data in this regard. This lack of real-world data on the use of Biosimilars in the daily practice and the availability of authentic copies in the region have undermined physicians’ confidence in prescribing legitimate Biosimilars. Over this session, we will revisit the international guidelines, emphasising the key quality and safety measures mentioned with an additional focus on the access and use of Biosimilars in Healthcare professionals daily practice. Followed by Q&A and Panel Discussion on Challenges and Regional Recommendations on Biosimilars
Speaker(s)
Virginia Acha, PHD, MSC
Global Lead, Global Regulatory Policy, Merck & Co., Inc., United States
Highlights and Analysis of the FDA & EMA Interchangeability Guidelines
Asmaa Fouad
Head Central Adm. of Biological, Innov. Products & Clinical Trials, Egyptian Drug Authority, Egypt
Maha Al Jaghbeer
Pharmacist, Head of Drug Registration Department, Jordan Food and Drug Administration, Jordan
The Health Authority’s Practices: the Experiences from Jordan
Abdulaziz Alsayyari
Executive Director of Quality Evaluation of Medicines, Saudi Food and Drug Authority (SFDA), Saudi Arabia
The Health Authority’s Practices: the Experiences from Saudi Arabia
Peter J. Pitts
President, Center for Medicine in the Public Interest (CMPI), United States
Biosimilars use in Practice: Challenges and Opportunities
Heba Khalil
Head of registration department, National organization For research and control of Biologicals, Egypt
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