Biosimilars & Biobetters USA 2015

June 22, 2015 7:12 AM


SMi’s Biosimilars & Biobetters USA Conference, is taking place on 16-17 November 2015 in New Jersey, USA.

SMi’s conference on Biosimilars & Biobetters USA 2015 will offer effective strategies and solutions for developing cost effective biosimilars for the future, through a series of exciting discussions, presentations and workshops, delivered by true biosimilar leaders and industry pioneers.

Join us in Iselin this November to listen to Sandoz regarding their first biosimilar approved by the FDA. John Pakulski, Head US Biopharmaceutical Regulatory Affairs, Sandoz, will be giving a spotlight presentation on Day 1 of the conference on “The first biosimilar approved by FDA”.

• Evaluating the regulatory landscape and pharmacovigilance of biosimilars
• Assessing and challenging the BPCIA’s dispute resolution process
• Understanding and recognising the technical challenges in biosimilars
• Discussing how to strategically plan and revolutionise biologics manufacturing
• Reviewing the status on biosimilars – Clinical development and continued progress
• Recognising commercialisation strategies & improving market development
• Developing further awareness on biobetters; are they the future?
• Examining unexpected in results in Immunogenicity testing

• Ravi S. Harapanhalli, Vice President, ParExel and former Senior Executive, FDA
• John Pakulski, Head US Biopharmaceutical Regulatory Affairs, Sandoz Inc.
• Chetak Buaria, Director, Business Development (Biosimilars), Merck Serono SA
• Carsten Brockmeyer, CEO, Formycon AG      
• Sean Xue, Director, Portfolio Management – Biologics, Dr. Reddy’s Laboratories, Inc.
• Andrea Laslop, Head of Scientific Office, AGES Regulatory Agency
• T.Shantha Raju, Scientific Director, Biologics Research, Janssen Research and Development
• Michael Kleinrock, Research Director, IMS Health
• Steinar Madsen, Medical Director, Norwegian Medicines Agency and many more.


Workshop A : A Regulatory Perspective on Biosimilars
Workshop leader: Ravi S. Harapanhalli, Vice President, ParExel and former Senior Executive, FDA

Workshop B: Development, Regulatory & Commercial Needs for Global Biosimilars
Workshop leaders: Gerry McGettigan, CEO & Regulatory Expert, and Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

View the full speaker line-up, conference programme and register online at

Location:                            Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Contact e-mail:       

Contact number:              Fateja Begum, +44 (0) 207 827 6184

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