About Middle East BiosimilarsFacts & Issues

Ata Nazer

Topics Facts about Biologicals Biosimilar vs. Generic Demand Drivers Market Opportunities Global Challenges ME Challenges Global & ME Registration Guidelines

Facts about Biologicals The first approval of a biological product in 1986 in the US In 2009 worldwide sales of biologicals reached US$93 billion 30% of all pharmaceutical research and development consists of biologicals By 2016 ten of the top 20 selling drugs will be biologicals In 2010 statistics report eight of the top 20 drugs are already biologicals

Biosimilar vs. GenericsBiosimilar Generic

Protein Based New version of originator product Minor change in formula Can cause drastic efficacy & Safety Change

Chemical Based

Off patent products

Same active ingredients as originator

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 protectionUS patent expiries by market volume based on 2007 US retail sales

Global Challenges Development Guidelines

Registration Guidelines

Pricing

ME ChallengesBiosimilar development will bring new challenges to ME manufacturers Regional Registration Guidelines Country Registration Guidelines

Development InvestmentIP for bettersimilars

Experienced Staffing

Market Entry ChallengesNeed for CROs EU vs. US Guidelines

Reference Pricing Comparability & Substitution Issues

Global/ME Registration Guidelines Many countries have issued some form of guidelines (Malaysia, Colombia, Mexico, Argentina, Venezuela, Taiwan, EU, Canada, U.S.A, Turkey, and Japan). WHO issued 2 drafts modelled on EU guidelines.

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 In Saudi Arabia, draft guidance was issued in August 2008, entitled Drug Master File Requirements for the Registration of Biosimilars.