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Hilton London Kensington Hotel

179-199 Holland Park Avenue

London, United Kingdom

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9th bi - annual BIOSIMILARS GLOBAL CONGRESS 2016 EUROPE | 26th - 28th Sepetember 2016 | Hilton London Kensington Hotel | London UK

Dear Colleagues, 

Paradigm Global Events are once again proud to announce our 9th - bi annual BIOSIMILARS GLOBAL CONGRESS 2016 EUROPE. 

Biosimilars is a type of biological product that is similar to another drug, which has already been approved by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy. 

The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations. 

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market. 

In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more. 


Prof. Andrea Laslop, Head of Scientific Office. AGES- Austria 

Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics, Japan 

Roman Ivanov, Vice President, Research and Development, Biocad, Russia 

Ray Cresswell, Vice President, Legal Counsel, GlaxoSmithKline 

Ming Wang, Vice President, Diabetes Disease Area Leader, Janssen, USA 

Dr. Fiona Greer, Global Director, Biopharma Services Development, Life Sciences, SGS 

Martin Bluggel, CEO, Co-Founder, Protagen Protein Services GmbH 

Dr. John Snyder, Research Fellow, Group Leader, Eurofins 

Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency 

Dr. Ekkehard Brockstedt, Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG 

Rodeina Challand, Biosimilars Consultant, formerly PRA International 

James Kent, PrescQIPP – Secondary Care Lead, Director of Pharmacy,Southend Hospital 

Olga Zielińska, Senior Specialist, Organizational and Legal Unit, Department of Drug Policy and Pharmacy, Ministry of Health, Poland* 

Alex Kudrin, Independent Biopharmaceutical Consultant, formerly VP, Head of Global Development, Celltrion 

Thomas Felix, Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen, Inc., USA 

Dr. Steinar Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency 

Gain Latest Insights on; 

Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market 

Know the strategies in place in developing and manufacturing biosimilars in emerging markets 

Establishing and integration of biosimilarity and comparability into developing Biosimilars 

Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance 

Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing 

Study the pre-clinical and clinical challenges associated with the development of biosimilars 

The importance of establishing partnerships and successful collaboration for Biosimilars business 

Learn the latest updates, trends and current Biosimilars market situations in different regions 

 What does the future hold for Biosimilars and Biologics 

Network with experts and leading drug developers, regulators and investors in the industry 

Who should attend? 

Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within: 

 Follow on Biologics/Follow on Proteins/Biosimilars 

Biologics/Biotechnology/ Biogenerics 

 Biopharmaceuticals/ Biotherapeutics 

 Legal Affairs 

 Intellectual property 

 Pricing and Reimbursement 

 Clinical Immunology 

 Regulatory Compliance 

 R & D 

 Preclinical and Clinical Development 

 New Product Development 

 Quality Affairs/ Quality Control 

 Principal Scientist 

 Pharmacovigilance 

 Chief Scientific Officer 

 Drug Safety & Risk Management 

 Process Control and Analytical Technologies 

 Business Development 

 Commercial Affairs 

 Marketing & sales 

 Legislation and Policy Advice 

 Licensing 

 Manufacturing 

 APIs 

 Bioequivalence 

 Drug and Safety Assessment 

 Market Strategy 

 Regulatory Affairs 

We look forward to having you be part of the event! 

Yours sincerely, 

Kimberly Tecson 

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