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Strategies for Successful Launches and
Manufacturing of mAbs

Event Overview

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.

Rich DiCicco
Chairman
Harvest Moon Pharmaceuticals USA, Inc.
Chairman, Biosimilars Asia 2013


To read the Chairman's message, click here »

As the next wave of biosimilars come onstream, the complexities of competing with next generation biologics and production will create both winners and losers

Biosimilars Asia 2013 adds a new dedicated programme on bio-manufacturing, focusing on development of mAbs and complex biosimilars

Under the umbrella of Drug Discovery & Development week, with an expanded Biosimilars Asia 2013 alongside China Pharma R&D and Pharma Legal Affairs

About Drug Discovery Week

As world attention continues to shift towards Asia, increasing and ongoing investment into the pharmaceutical industry has come to fruition, matched by rapidly growing demand from the region. Funded by mostly private and emerging government supported initiatives, China is leading efforts as the future source of innovation and producer of quality medicines. Whether in new drug and vaccines discovery and development or in biosimilars, the time is ripe in China!

Key speakers this year include:

Dr Georg Feger
Head of Preclinical Research, Biosimilars
Merck Serono, Switzerland
Dr Michel Mikhail
Chief Regulatory Officer, Executive Vice President, Global Regulatory Affairs, Fresenius Kabi, Germany & Member, Executive Committee and Board, European Generic Medicines Association (EGA), Belgium
Dinkar Sindhu
Senior Director and Head, Merck Serono Alliance
Dr Reddy’s Laboratories, India

To see the full speaker line-up this year, click here »


Pre-Conference Workshops – 20 May 2013
A: Essentials to Compete Profitably with Authorized Biosimilars

Led by:
Alan Sheppard, Global Head of Generics, Thought Leadership, IMS Health, UK
Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA
Dr Janet M McNicholas, Partner, Jones Day, USA

B: The Art of Guanxi – Principles for Successful Business in China

Led by:
Seth Goldenberg, Senior Principal Scientist, NAMSA, USA
Angela Luo, Senior Partner, Beijing Long An Law Firm Shanghai Branch, China

Post-Conference Workshops – 23 May 2013
C: Due Diligence for PharmaBiotech Collaboration and R&D Agreement

Led by:
Lewis Ho, Partner, Dechert LLP, Hong Kong

D: Gaining Biosimilars Approval in US and EU

Led by:
Dr Anita O'Connor, Managing Partner, Anita O'Connor Consulting, USA

Find out more about the workshops, click here »


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

 

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