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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.
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
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!
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 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 |
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 »
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- 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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Rich DiCicco
