Professional Documents
Culture Documents
About Middle East Biosimilars
About Middle East Biosimilars
Ata Nazer
Topics
Facts about Biologicals Biosimilar vs. Generic Demand Drivers Market Opportunities Global Challenges ME Challenges Global & ME Registration Guidelines
Protein Based New version of originator product Minor change in formula Can cause drastic efficacy & Safety Change
Chemical Based
Demand Drivers
Growing use of biologicals The need for more costeffective treatments Access of less privileged patients to biosimilars
Market Opportunity
According to IMS Health, by 2015 spending on biosimilars will exceed US$2 billion annually, or about 1% of total global spending on biologicals Between 2011 and 2015 a total of US$17 billion worth of sales in the US alone will lose patent protection
US patent expiries by market volume based on 2007 US retail sales
Global Challenges
Development Guidelines
Registration Guidelines
Pricing
ME Challenges
Biosimilar development will bring new challenges to ME manufacturers Regional Registration Guidelines Country Registration Guidelines
Development Investment
IP for bettersimilars
Experienced Staffing
In the Middle East, there is some consensus to use the EMEA guidelines as the basis of Regional guidelines for the registration of biosimilars . In Saudi Arabia, draft guidance was issued in August 2008, entitled Drug Master File Requirements for the Registration of Biosimilars.