Biosmiliars Asia 2013

IBC’s 4th Annual Biosimilars Asia 2013 is the region’s largest gathering of leading and future stakeholders. Lively debates, insightful case studies and in-depth market analysis provide maximum learning. Keep abreast of the latest in biosimilars development and commercial strategies. Engage with your peers in competing to bring affordable medicines to market.

NEW! Bio-manufacturing challenges in the efficient supply and production of quality biosimilars.

Key Topics to be Covered in 2013 Include:

• Successful navigation of the evolving biosimilars landscape

• Risks & returns to consider before entry

• Strategic collaborations to strengthen value chain

• Product development & new market expansion

• Developing sustainable competitive strategies

• Winning market acceptance

What’s New for 2013?

• EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved in the EU. The changes in policy mean that EMA will accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA)

• June 2012: India announced its new biosimilar regulations which will accept foreign preclinical data

• Abbott petitions FDA to prevent Humira biosimilars on the grounds of Fifth Amendment rights, stalling biosimilars entry into the US