Latest Biosimilars in Asian Scenario

Formal legislation to ensure rigorous regulatory and testing standards for biosimilars (in place of the less regulated ‘copy biologics’) began to appear in 2008–2009, with Australia, Malaysia, South Korea, and Japan among the first countries in the region to implement these strict approval requirements. More recently, India (2012) and China (2015) have finalized their own national guidelines. There are currently more biosimilar products in development across the Asia-Pacific region than anywhere else in the world, leading to a wealth of opportunities for investors and patients to take part in biosimilar clinical trials. This track covers topics such as: 

Formal legislation to ensure rigorous regulatory and testing standards for biosimilars (in place of the less regulated ‘copy biologics’) began to appear in 2008–2009, with AustraliaMalaysiaSouth Korea, and Japan among the first countries in the region to implement these strict approval requirements. More recently, India (2012) and China (2015) have finalized their own national guidelines. There are currently more biosimilar products in development across the Asia-Pacific region than anywhere else in the world, leading to a wealth of opportunities for investors and patients to take part in biosimilar clinical trials.

  • Prospects of Biosimilars in Asian market
  • Approved Biosimilars in Asia-Pacific Region
  • Regulatory guidelines in the Asia-Pacific region
  • Market strategy, analysis and Risk Management for Biosimilars in Asia market

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