On May 20th and 21st 2014 Roche arranged meeting in Saudi FDA premises as well as Marriott Riyadh with KOLs (Oncologists, Hematologists and Rheumatologists) and also key decision makers (Purchasers and clinical pharmacists) in different hospitals (King Faisal Spec. Hospital, National Guard Hospital, Security Forces Hospitals, Ministry of Defense and Aviation-MODA and Ministry of Health) where almost 70 participants were attending the presentation conducted by medical and regulatory experts from Roche global team in Basel. The session was moderated by Prof. Ibrahim Alsarra (Head of Saudi Pharmaceutical Society and Professor of Biopharmaceuticals in King Saud University – Riyadh, Faculty of Pharmacy)

The presentation highlighted key topics related to Innovator products and technology behind producing them as well the value they offer to the patients.

Also they shed some lights on Biosimilars and their existence in the market in addition to the regulation governing their approval from different regulatory bodies among the world especially EMA and USFDA.

Regulations currently being under release in GCC especially Saudi FDA being the main market in GCC having most of its products imported as innovator ones were discussed as well.

Main topics discussed during both meeting included:

• Roche as an Innovator in Biotechnology industry

• Global regulatory challenges for Biosimilars

• Outlook of Roche products pipeline

• Key aspects in Biosimilar development and clinical programs

• Stepwise approach to establish similarity based on analytical, preclinical, clinical comparisons between Biosimilars and reference product

• Difference between new biologics drug development and Biosimilars development program