Biosimilars Global Congress 2013 Europe


Background Info

The Biosimilars Global Congress 2013 Europe

Paradigm Global Events is proud to present The Biosimilars Global Congress 2013 Europe.

The market for Biologics is currently representing 16% of global pharmaceutical expenditure and significantly out-performing branded sales, it will continue to conquer the global market as it makes way for more innovative products deliver new treatment option.

The market for Biosimilars is expected to reach between US $1.9 billion – $ 2.6 billion by 2015 and is expected to become an increasingly large part of world market for global pharmaceutical with the potential of reaching 50% share. The lost of patent protection of the twelve top-selling Biologics by 2020 will trigger an estimated sales of $24 billion in Europe and $30 billion in the United States without having to mention the sales from the phamerging markets (China, India, Brazil, Mexico).

Why attend?
• In depth market analysis will provide maximum knowledge to keep ahead of the latest trend in Biosimilar developments and commercial strategies.
• Understanding the complexities of competing with next generation biologics and discuss the obstacles in bringing the next generation of Biologics to the market.
• Examine the perspective, risk and opportunities of the evolving market of Biosimilars.
• Learn methods of minimizing the cost and optimizing result in producing high quality Biosimilars.
• Gain better understanding of the European and US regulations and guidelines for Biosimilars including variations and new developments.
• Explore the difference and effect of Generics to the commercialization of Biosimilar medicine.
• Gain better insights into conducting trials, assessing immunogenicity and pharmacovigilance in Biosimilars.
• Focus on issues in developing Biosimilar mAbs.
• Explore CMC requirement in order to produce high quality similar biologic product in comparability with reference product.
• Network with experts and leaders of the industry.

A “Must attend??? Biosimilars Global Congress in Europe for 2013 for:
• 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
• Health Economics
• Process Control and Analytical Technologies
• Business Development
• Commercial Affairs
• Marketing & sales
• Intellectual Property
• Legislation and Policy Advice
• Business Development
• Licensing
• Manufacturing
• APIs
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs


Pre-Conference Workshop: 18th, September 2013
09:30 – 13:00 Regulatory and Clinical Issues for Global Market – Led by Rodeina Challand, PRA International

Pre-Conference Afternoon Workshop – 18th September 2013
14:00 – 17:30 Biosimilars: Is the Risk worth the Reward – Led by James Harris III, CEO, Healthcare Economics LLC

• Assessing the promise and potential of Biosimilars
• Latest progress in biosimilars development
• Providing progress and acceptance of biosimilars
• Payer perspectives and formulary acceptance
• Biosimilar ROI consideration

Post Conference Workshop – 20th September 2013
14:40 – 17:10 From Development: Biosimilars MAbs to Market – Led by Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals USA

Key Speakers

Day 1

Day 1 – 19th September 2013

09:00-09:30– Registration (Coffee Refreshment)

09:30-09:40 – Chairman’s welcome remark – Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International


– Biosimilars Market Overview

09:40- 10:20 – Current Commercial Trends in Biosimilars: Seeing the Bigger Picture
• Assessing the promise and Potential of Biosimilars
• Biosimilar Uptake and Strategies for Market Penetration
• Biosimilars ROI Considerations
James Harris III, CEO Healthcare Economics USA

10:20-11:00 – Biosimilars 2015-2020 – A Market and Commercial Perspective
• Overview of the pharmaceutical and biologics markets
• Analysis of biosimilars markets and trends – past, present and future
• Commercial and operational considerations of successfully navigating the evolving biosimilars landscape
Dr. Steve Flatman, Head of Biosimilars Research and Development, Lonza Biologics Plc

11:00-11:40 – Networking morning refreshment break (Exhibitors Area)

11:40-12:20 PANEL DISCUSSION: Obstacles and hurdles for entering the Biosimilars market
• An interactive discussion on the barriers of entry for developing biosimilars; discussing topics such as
• Cost of development
• Legal requirements
• Technology demands
Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals, USA

Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International
James Harris III, CEO Healthcare Economics USA


– Clinical Issues & Studies for Biosimilars & Pharmacovigilance
– Sponsored Spotlight Presentation

12:20-13:00 Challenges and obstacles in conducting clinical trials for Biosimilars
Dr.Nigel Rulewski, Vice President, Global Strategic Drug Development, Quintiles

– Lunch Break

14:00-14:40-Biosimilars–Barriers to Patient’s access and to market entry
• Originator Defenses to Contain the Impact of Biosimilars
• Two types of Deeply Discounted Second Brands
• Impact on First-to-Market Biosimilar mAbs
• The Current Thinking of Originators
• Legal Basis of the Deeply Discounted Second Brand
• Strategies to counter Deep Discounted Second Brands
Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals, USA

14:40-15:20Biosimilars Monoclonal Antibodies- key regulatory aspects for development and approval – European Regulation
• European guidelines and international counterparts
• Questions and milestones during development
• Challenges and approval and post marketing
Univ. Prof. Andrea Laslop, MD Head of Scientific Office Austrian Agency for Health and Food Safety, AGES MEA

15:20-16:00– Networking afternoon refreshment break (Exhibitors Area)

16:00-16:40– Biosimilars containing monoclonal antibodies
• Clinical and non-clinical issues
• Risk assessment and management
• mAbs update affecting Biosimilars
Isabel Zwart, Senior Consultant, PAREXEL International

16:40-17:20Interchangeability and Substitution
• Traceability and safety of biosimilars
• International Non-proprietary Name (INN) for a new biosimilars
• Current global status regarding substitution and interchangeability
Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International

17:20-17:30– Closing remarks – Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International

17:30 – Networking Drinks Reception. Take your discussions further and build new relationships in a relax and informal settings.

Day 2

Day 2 – 20th September 2013

09:00-09:30– Registration

09:30-09:40– Chairman’s opening remarks James Harris III, CEO Healthcare Economics USA


– Biosimilars Quality Development Update and Regulatory Update

9:40-10:20– Presentation Title to be announced shortly
Ashish Dugar, Global Medical Team Leader, Biosimilars, Pfizer

10:20-11:00– Establishing and demonstrating Biosimilarity – The CMC part
• Reference product monitoring
• Monitoring Biosimilarity from Cell line to GMP Process
• State of the art protein analytics and regulkatory demands to demonstrate Biosimilarity
• Case studies for Analytical testing to establish and demonstrate biosimilarity
Martin Bluggel, Chief Business Officer, Protagen Protein Services GmbH

11:00-11:40– Networking morning break (Exhibitors Area)

11:40-12:20– Key Patent infringement issues in relations to Biosimilars
• Lack of linkage between the patent and regulatory systems
• Difficulties in obtaining evidence to assess infringement
• Defences, such as the Bolar and research exemptions
• Spc Issues
Katie McConnell, Of Counsel, Hogan Lovells International LLP

12:20-13:00– Biosimilars Regulatory Update
• The rules governing the marketing of Biosimilars
• Update on Biosimilars guidance developed and issued by the European Medicine Agency
• Overview of the Biosimilars authorized to be placed on the market in EU.
Alexander Roussanov, Associate, Hogan Lovells International LLP

13:00-14:00– Networking Lunch Break

14:00-14:40– Biosimilars: Driving on Global Commercial Potential through the Emerging Markets
• Understand how developing healthcare policy in the emerging markets plays to the biosimilars opportunity
• Identify key emerging markets particularly conducive to the biosimilars opportunity
• Determine non-pricing options for achieving competitive advantage relative to other biosimilars
Cyrus Chowdhury, CEO & Managing Director, CB Partners


– Post Conference Workshop

14:40-15:40 – First Part: From Development: Biosimilars MAb to Market
• Biosimilar mAb global regulatory guidelines drive development of biosimilar mAbs
• Various development programs for biosimilar mAbs
• Designing global clinical trial programs for biosimilar mAbs

15:40-16:10– Networking afternoon refreshment break

16:10-17:10- Second Part: From Development: Biosimilars MAb to Market
• Selecting the right marketing partners for biosimilar mAbs
• Executing a well designed marketing plan for biosimilar mAbs in the right territory
• Risks and rewards of being late with biosimilar mAbs

17:10-17:20- Chairman’s closing remarks – James Harris III, CEO Healthcare Economics USA



Associate Sponsors

Quintiles is the world’s leading biopharmaceutical service provider
With a network of more than 27,000 professionals working in more than 80 countries, we have helped develop or commercialize all of the top 50 best selling drugs on the market.

With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes. We address the needs of the biopharmaceutical industry and broader healthcare industries, including payers and providers. We use our expertise and insights to help customers optimize the value of their drug development, commercialization and health care delivery.

We can support our customers from initial human testing through patent expiration, from strategy through planning and execution. Through our extensive range of services, we solve our customers’ biggest challenges: decreasing costs, improving productivity, and saving time. The broad scope of our services helps our customers rapidly assess the viability of a growing number of potential new therapies, cost-effectively accelerate development of the most promising ones, successfully launch new products to market and evaluate their impact and appropriate use in patients. All along, we work with an unwavering dedication to patients, safety and ethics.


Genovis offers enzymes that can make all the difference in antibody characterization. FabRICATOR (IdeS) robustly and rapidly generates precise F(ab’)2 fragments and IgGZERO (EndoS) that allows for quick declycosylation of IgG. In combination with mass spectrometry analysis these unique enzyme s can facilitate and improve antibody characterization from discovery to production and quality control.


Protagen Protein Services GmbH

Protagen Protein Services GmbH is an international leading specialist in the fields of Protein Characterization, Biopharmaceuticals and GMP-compliant protein analysis. 15 year’s experience in business and the comprehensive, GMP compliant spectrum of analytical methods ensure highest quality the customers in the pharmaceutical, biotech, and the entire life science industry.

Besides a large number of new biological entities (NBE) currently in development, Protagen has supported a vast number of customer projects to develop biosimilars for Etanercept, Rituximab, Infliximab, Trastuzumab, Erythropoietin, Adalimumab, Bevacizumab, Filgrastim, Insulin, Interferons and several other products. PPS data sets are accepted by EMA, FDA, and Korean-FDA for scientific advices, phases 1 to 3 or release testing.

Media Partners

Media Partners

PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE’s more than 25,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. For further information please visit:

Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. For further information please visit:

European Life Science is the premier journal devoted to presenting outstanding research and researchers within the life science fields. For further information please visit: is the leading online product and application publication for laboratory scientists featuring the latest news, application articles, videos, product directory and product reviews. Membership is fast, free and provides access to all of the SelectScience services. is a unique video news channel for laboratory application and product information. For further information please visit:

InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to, Pharmafile and Pharmafocus. For further information please visit: is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email:

BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit

Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision- makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: