2nd Biosimilars Congregation 2013
Offering our customers the knowledge and connections for a profitable business
  • Lincoln Tsang Arnold & Porter

  • Ranjith Gopinathan Frost & Sullivan

  • Martin Bluggel Protagen Protein Services

  • Kristie C. Kuhl Makovsky (USA)

  • Peter Wittner Interpharm Consultancy (Former Managing Director Ranbaxy UK)

  • Richard Dennett Voisin Consulting Life Sciences (France)

  • Christopher Holloway ERA Consulting Group

  • Duncan Emerton Datamonitor

  • Steinar Madsen Norweigen Medicines Agency

  • Sandy Eisen Frontline Pharma Consulting

  • Marguerite Mensonides-Harsema Medac

  • Bruno Flamion NDA Regulatory Advisory Board

  • Mateja Urlep TikhePharma

  • Jean-Yves le Cotonnec Triskel Integrated Services

  • Paul Greenland Hospira

  • Malcolm I Mitchell Eli Lilly

  • Alex Kudrin MHRA (Former Medical Director, Takeda Pharmaceuticals)

  • Cecil Nick Parexel

  • Anne Cook MHRA

  • Paul Tredwell Sandoz

19th & 20th February 2013, Marriott Regents Park, London UK

“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

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  • Day One
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  • Delegates
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  • Venue
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According to Global Industry Analysts Inc.. The global market for biosimilars is forecast to reach US$4.8 billion by the year 2015. By 2020, some $55 Billion worth of biologic patents are due to expire. Key factors driving market growth include patent expiries of key biological drugs, cost containment measures from governments, aging population, and supporting legislations. The recent establishment of regulatory guidelines for biosimilars in the US is expected to add further momentum to the growth of the global biosimilars market. Increasing pressure from governments and insurers for greater biologic competition, there exists an incredible opportunity for biosimilar producers to capitalise on what is set to become the fastest growing sector of the pharmaceutical industry.

The barriers to entry for this lucrative market however require that companies establish and harmonise carefully planned regulatory, clinical and marketing strategies.  Innovators and biosimilar applicants need to find answers to the current myriad of commercialisation questions that face the market. Those to establish their market presence first will dictate the success of companies in the biosimilar space.

Europe holds the highest number of biosimilar approvals, and this number will continue to increase in the near future. Further biologic patent expiries will boost the number of biosimilars to be approved, thereby bringing in an increased number of products that will help increase market size and competition among market participants. The biosimilars market is in the nascent stage of the industry life cycle with limited market and product development experience. However, there is a significant market opportunity from patent expiries. High initial investments are still a major barrier for new entrants. Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market.

The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  Hence, this 3rd Biosimilars Congregation 2013 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development.

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 2nd Biosimilars Congregation 2013. I wish and pray that all our efforts will be beneficial to our industries folks at large.


  • How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market? The future of next generation Biosimilars
  • How are policy makers shaping the contours of this new generic frontier, and what implications they have for current biologic drug development and patent protection?
  • Next generation monoclonal antibody development and clinical challenges with biosimilar drug development
  • Research-based industry biosimilar strategies
  • Commercial challenges and opportunities - strategies to develop Biosimilars
  • Learn to implement best practices through recent successful strategies and business models – real time case studies
  • Considerations for the analytical similarity assessments when designing a biosimilar development program
  • Determining the right investments & potential returns from Biosimilars
  • General scientific principles in conducting comparative structural and functional analyses, animal testing, human PK and PD studies, clinical immunogenicity assessment, and clinical safety and effectiveness studies
  • Considering the growing importance of biobetters over biosimilars
  • Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval
  • Understanding the current regulatory approval standards for Biosimilars in Europe and the US, including for monoclonal antibodies
  • Be part of a major networking opportunity


CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Biopharmaceuticals/ Biotherapeutics
  • Follow on Biologics/Follow on Proteins/Biosimilars
  • Biologics/Biotechnology/ Biogenerics
  • Legal Affairs
  • Intellectual Property
  • Health Economics
  • Pricing and Reimbursement
  • Clinical Immunology
  • Principal Scientist
  • Chief Scientific Officer
  • Process Control and Analytical Technologies
  • Analytical Characterisation
  • Regulatory Compliance
  • Pharmacovigilance
  • Drug Safety & Risk Management
  • Quality Affairs/ Quality Control
  • New Product Development
  • Process Science
  • Portfolio Management
  • Research & Development
  • Business Development
  • Business Operations
  • Scientific Affairs
  • Commercial Affairs
  • Marketing


2nd Biosimilars Congregation 2013 – “Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway.  Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

09:30 – Chairperson opening remarks

Kristie C. Kuhl, Senior Vice President, Makovsky (USA) 


09:40 – Morning Keynote Address – EU regulatory approaches to biosimilars

  • From comparability to biosimilarity
  • Endpoints for biosimilarity clinical trials
  • Extrapolation of indications
  • The safety and immunogeniciity of biosimilars

Bruno Flamion, Member, NDA Regulatory Advisory Board

10:20 – Analysing the next generation monoclonal antibody development & the clinical challenges with biosimilar drug development

  • What are the special requirements for demonstrating biosimilarity of monoclonal antibodies?
  • The advancement of monoclonal antibody technology and the enhancement of oncologic disease therapy by next generation antibody drugs
  • Promising early clinical studies and growing interest
  • The clinical challenges in the biosimilar drug development: manufacturing, preclinical testing, and clinical trial implementation
  • Future opportunities

Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting 

11:00 – Morning Coffee/Tea & Discussion


11:20 – Keynote Panel Discussion: Challenges and Opportunities

  • Update on biosimilars in Europe - Current trends for EU biosimilar approvals, and new and future guidelines – Get yourself updated.
  • Biosimilar sales forecast - How large is the opportunity?
  • Opportunities to drive your longer term biosimilars strategy – Possible strategies to enter in emerging markets
  • Identifying a roadmap for success for the EU biosimilars market to minimise costs and maximise return on investment
  • Scientific advice and how to achieve the best dossier
  • Strategies for change: how can we ensure that biosimilars are still safe and efficacious, but also affordable and globally accessible for patients?
  • What characteristics of biosimilar partnerships are critical in developing commercially successful biosimilars?


Kristie C. Kuhl, Senior Vice President, Makovsky (USA)


Alex Kudrin, Medical Assessor in Licensing of Biological Products, MHRA (Former Medical Director, Takeda Pharmaceuticals)

Paul Tredwell, Head of Biopharmaceuticals, Sandoz

Ranjith Gopinathan, Program Manager, Life Sciences, Healthcare, Frost & Sullivan

12:10 – Technology transfer and comparability strategies for biosimilars

  • The nature of the challenge: how to set your sights to meet EU and US regulatory approval
  •  Why technology transfer is essential across all stages of the product development lifecycle
  •  Why comparability is king: prospective issues and mitigation
  •  Case study of a failed technology transfer for a biosimilar product
  •  Getting technology transfer right first time: Putting current biosimilar and ICH guidelines to work

Richard Dennett, Director, Voisin Consulting Life Sciences (France)

12:50 – Networking luncheon


14:10 – Capturing the mAb biosimilar opportunity in Germany

  • Historic uptake of generics and biosimilars in Germany: key learnings
  • Drivers and bariers form mAb uptake in Germany: aligning the players
  • mAb opportunity in autoimmune disease: stakeholders and entry strategy

Marguérite Mensonides-Harsema, PM Portfolio Development Autoimmune, Medac

14:50 – Afternoon Keynote Panel Discussion: Biosimilars Development and Impact on Clinical Practice

  • Will biosimilars increase access to biologic therapies in chronic debilitating conditions?
  • How are Biosimilars developed?
  • What are the regulatory challenges and expectations currently in the EU and what can we expect in the US?
  • What does an ideal legal/regulatory framework looks like for a successful Biosimilar model?
  • What impacts will we see in prescribers, payers and patients and what does this mean for drug developers?
  • Analysis on the current situation in terms of biosimilar infliximab


Kristie C. Kuhl, Senior Vice President, Makovsky (USA)


Malcolm I Mitchell, Senior Medical Fellow, Clinical Pharmacology, Eli Lilly

Steinar Madsen, Medical Director, Norweigen Medicines Agency

Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting

15:40 – Afternoon Tea/Coffee

16:00 – Demonstrating Biosimilarity – Considerations on the Comparability Exercise

  • Quality strategies in developing Biosimilars – From Clone pool selection to GMP production
  • Regulatory aspects of structural comparability
  • State-of –the-art analytics for CMC section
  • Actual Case studies for Demonstrating Biosimilarity

Martin Blüggel,
Chief Business Officer, Protagen Protein Services

16:40 – Chairperson’s closing remarks and end of conference

Kristie C. Kuhl, Senior Vice President, Makovsky (USA)

16:50 – 18:00 Networking Drinks Session

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

09:30 – Chairperson opening remarks

Duncan Emerton, Director and Biosimilars Practice Lead, Datamonitor


09:40 – Morning Keynote Address 1: "Opportunities in European Biosimilars Market"

Ranjith Gopinathan, Program Manager, Life Sciences, Healthcare, Frost & Sullivan

10:20 – Key drivers for the development of biosimilars

  • What are the key opportunities in the emerging markets?
  • Analysing the key action plan necessary to fast-track the development of current biosimilars market
  • Surveying the battlefield: how are the key players lining up?
  • Preparing a ‘biologic experience’ for biosimilar uptake in Europe

Jean-Yves le Cotonnec, CEO, Triskel Integrated Services

11:00 – Morning Coffee/Tea & Discussion

11:20 – Panel Discussion - Biosimilars vs. Biobetters

  • Considering the growing importance of biobetters over biosimilars
  • Considering and comparing facts like – ROI, gaining competitive edge, faster approval timeline and Innovator responses to the threat of competition
  • Successful methods for biobetter developments
  • Partnering trends of Biosimilars & Biobetters in emerging markets
  • What different development approaches are companies taking?
  • What will be the involvement of companies in the U.S./EU vs. those in developing countries?


Duncan Emerton, Director and Biosimilars Practice Lead, Datamonitor


Anne Cook, Biologicals Quality Assessor, MHRA

Paul Greenland, Biosimilars and Proprietary Marketing Director – EMEA, Hospira

Jean-Yves le Cotonnec, CEO, Triskel Integrated Services

12:10 – Branding and Promotional Considerations for Biosimilars

  • How distinct does the follow-on product name have to be from the original?
  • New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development
  • The benefits and drawbacks of a unique nonproprietary name to distinguish biosimilars from reference products
  • What are the expected commercialization challenges and discover various ways to overcome them
  • Protecting your biologic through enforcement and risk management strategies
  • Why is patent risk higher for biopharmaceuticals than traditional small molecules?

Mateja Urlep, Founder & CEO, TikhePharma

12:50 – Networking luncheon


14:10 – Afternoon Keynote Address – Determining the type & volume of clinical data that is essential for establishing biosimilarity - An EU, FDA, and RoW perspective

  • What will FDA require in terms of clinical testing?
  • Striking a balance between requiring larger and more sophisticated trials and facilitating market entry for biogenerics 
  • Understanding the patient perspective in the biosimilar conversation

                o    Biologic and biosimilar safety and efficacy
                o    Pharmacovigilance: collecting, monitoring, researching, assessing and evaluating adverse events
                o    Cost to the patient
                o    Therapeutic substitution issues
                o    Barriers to care

  • What level of support will FDA require to get approval?
  • Extrapolating data obtained in clinical trials for a reference product to support biosimilar applications

Cecil Nick, Vice President, Biotechnology, Parexel


14:50 – Pricing and Reimbursement of Biosimilars – Identifying successful access & pricing strategies

  • Challenges and threats in terms of market   access – identify and break through
  • Making sure in the development plan that a biosimilar gets favourable pricing and market access evaluation at launch?
  • Determining the right investments & potential returns from Biosimilars
  • Lessons from the EU Pricing Challenges for biosimilars entrants
  • Coping with cuts in government expenditure
  • Ensuring long-term sustainability in Global healthcare, by reducing the cost of biologics

Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK)

15:30 – Afternoon Tea/Coffee


15:50 – Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

  • A brief recap of recent regulatory developments in Europe and the United States
  • Current Biosimilars practices in UK and examining various methods for improvement
  • Assessing the government incentives and initiatives currently in place and planned, around EU biosimilars
  • Analysing the developing biosimilars regulatory framework in the U.S.
  • Reviewing and applying comparability studies by the FDA
  • Legal for Biosimilars - Turning antitrust laws to your advantage in the generics and biosimilars


Christopher Holloway, Group Director of Regulatory Affairs, ERA Consulting Group


Lincoln Tsang, Partner, Arnold & Porter

Peter Wittner, Senior Consultant, Interpharm Consultancy (Former Managing Director Ranbaxy UK)

16:30 – Chairperson’s closing remarks and end of conference

Duncan Emerton, Director and Biosimilars Practice Lead, Datamonitor

16:40 – End of the 2nd Biosimilars Congregation 2013

Lincoln Tsang


Arnold & Porter

Ranjith Gopinathan

Program Manager, Life Sciences, Healthcare

Frost & Sullivan

Martin Bluggel

Chief Business Officer

Protagen Protein Services

Kristie C. Kuhl

Senior Vice President

Makovsky (USA)

Peter Wittner

Senior Consultant

Interpharm Consultancy (Former Managing Director Ranbaxy UK)

Richard Dennett


Voisin Consulting Life Sciences (France)

Christopher Holloway

Group Director of Regulatory Affairs

ERA Consulting Group

Duncan Emerton

Director and Biosimilars Practice Lead


Steinar Madsen

Medical Director

Norweigen Medicines Agency

Sandy Eisen

Chief Medical Officer

Frontline Pharma Consulting

Marguerite Mensonides-Harsema

PM Portfolio Development Autoimmune


Bruno Flamion


NDA Regulatory Advisory Board

Mateja Urlep

Founder & CEO


Jean-Yves le Cotonnec


Triskel Integrated Services

Paul Greenland

Biosimilars and Proprietary Marketing Director EMEA


Malcolm I Mitchell

Senior Medical Fellow, Clinical Pharmacology

Eli Lilly

Alex Kudrin

Medical Assessor in Licensing of Biological Products

MHRA (Former Medical Director, Takeda Pharmaceuticals)

Cecil Nick

Vice President, Biotechnology


Anne Cook

Biologicals Quality Assessor


Paul Tredwell

Head of Biopharmaceuticals



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Excellent cross section of up to date & future directions of Biosimilars

Richard Dennet
Director, Voisin Consuting Lifesciences

Good Discussion about commercial Challenges and lessons with 1st class biosimilar products and challenges/ development, regulatory and commercial with biosimilars MABs

Alex Kudrin
Medical Assessor in Licensing of Biological Products, MHRA

For access to the presentations for this conference, please email us at presentations@virtueinsight.com

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