Biosimilars Day 1 - Tuesday 31st October 2017


08:00 Registration opens


08:30 Registration and refreshments


How to make Biosimilars a Successful Business


Welcome - Jessica Robinson, Project Director, World Biosimilar Congress

Adam Levysohn

'Unlocking the value of Biosimilars' - The market access perspective

  • Negotiating price and return
  • Finding a ‘go to market’ approach
Ingrid Schwarzenberger

Switch studies versus demonstrating interchangeability

  • US Interchangeability requirements: analysis and feasibility
  • Industry comments
  • European perspective
  • Switch studies: design and results
Adam Levysohn

International stakeholders panel discussion: What does it take to get biosimilars moving in a country?

  • Consisting of industry panellists, physicians, pharmacists, patient advocacy groups, payers, regulators and health authorities, the 360° Perspective Panel allows the whole industry to come together to discuss and debate the sector’s most pertinent topics of the day.
  • With no guarantee that physicians will prescribe biosimilars interchangeably with reference products, what more does the industry need to do to encourage biosimilar uptake within healthcare?
  • What can we learn from gainsharing practices? Carrot & stick models, which works better?
  • How influential are payers in the speed in which biosimilars are taken up in healthcare systems?
  • How does the industry envisage overcoming the challenge that patient communities are generally unaware of this new, yet important, category of medicines?

Networking refreshment break

round tables

Plenary Roundtable Discussion Session

8 senior level tables hosted by thought leaders on key challenges and opportunities in antibody drug development. Participants are invited to join the group discussions on a topic of importance to them.
  • ROUNDTABLE 1 Achieving regulatory success: Understanding the principles and the expectations
  • Gopalan Narayanan

    Gopalan Narayanan, VP, Complex Bio, Voisin Consulting Life Sciences (VCLS)

  • ROUNDTABLE 2 What does sustainability mean for the industry? How can all stakeholders collaborate to create a sustainable environment?
  • Peter Jorgensen

    Peter Jorgensen, Chief Executive Officer, I.G.L.

  • ROUNDTABLE 4 Rare disease and orphan drug biologics as biosimilar candidates
  • Richard DiCicco

    Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

  • ROUNDTABLE 5 Tackling the manufacture and downstream processing of biosimilar products
  • ROUNDTABLE 7 Novel techniques and technologies for characterisation, assay development and extrapolation
  • WORKSHOP HOSTED BY NICE Understanding issues around market access
  • Margaret Dolan

    Margaret Dolan, Regional Pharmacy Procurement Specialist, N.H.S.


    Speed Networking

    A fun, exciting and effective way to make a lot of initial connections (in a very different environment from the standard business networking meetings)


    Catherine Evans

    Lunchtime workshop: Overcoming the challenges of intact biotherapeutics characterization

    Lunchtime Workshop: Overcoming the challenges of intact biotherapeutics characterization with ultra-high resolution mass spectrometers and the latest in automated biopharmaceutical software package Biopharma Compass 2.0

    Biosimilar and biobetter development and clinical challenges and how to overcome them

    Market access strategies, opportunities and commercial challenges

    Chair: Karsten Roth, Director Clinical Operations, Cinfa Biotech

    Chair: Gopalan Narayanan, Vice-President, Disruptive Biologics, Voisin Consulting Life Sciences


    What is the role of specialised nurses in the decision-making process of a patient’s treatment of in the hospital treatment regime?

    • Change management – how to build confidence with the patient?
    • Why is a switch initiated and what does this mean?
    • How will a nurse interact with the patient?
    • Examples of switches being made in key therapeutic areas such as Rheumatology, Oncology, Inflammatory Bowel Disease and other autoimmune diseases and Endocrinology

    Are biosimilars the new ‘EasyJet’ of biologics? A question of plurality, chance and market segmentation

    • Using low-cost airlines to explore the future of biosimilar commercialisation
    • Will this be a solely price driven, ‘cheapest wins’ approach for biosimilars?
    • Positioning and incentives with health authorities

    Patient Recruitment in Biosimilar Studies - Challenges and Solutions 

    •     What are the key challenges we face?
    •     What do we need to do differently to achieve recruitment goals?
    •     How can we utilise data to aid recruitment?

    Understand the competitive landscape - the importance of an integrated evidence plan

    •     A Review of the current healthcare landscape
    •     A review of current drug launch success
    •     An Integrated Evidence Plan – understanding value beyond just price  
    Robert Wojciechowski, Director, Global Regulatory Consulting, INC Research/inVentiv Health

    Afternoon refreshments


    Biosimilar development in emerging markets


    Market access strategies, opportunities and commercial challenges


    Chair: Parminder Kaur, CEO, RegPak BioPharma


    Chair: Gianluca Trifirò, Department of Biomedical Sciences, Dentistry and Morphological and Functional Images, University of Messina – Italy


    The changing landscape for biosimilar and biobetter drugs in Brazil and Latin America

    • How the Brazilian government is incorporating biosimilars into the public health service
    • The Brazilian Biosimilars Market
    • Manufacturing Biosimilars in Brazil
    • Strategic partnerships
    Don Stewart, President and Chief Executive Officer, PlantForm Corporation

    Project management for biosimilars

    •     Some generic principles
    •     Some biosimilar specific principles
    •     The three defining moments for successful biosimilar development

    Challenges & strategies to develop emerging markets for biosimilars

    • Main challenges in emerging market
    • Suitable and feasible strategies in different territories
    • New Regulations & Opportunities for biosimilar business in China

    A mid-size company perspective on biosimilar development: from the idea to the market

    • The biosimilar market as an attractive arena for specialised players
    • Overcoming the challenges of biosimilar development with a lean team and efficient development programs
    • Choosing the right path for market entry

    Improving market access and shaping regulatory environments in Spain

    • Improving knowledge dissemination of what a biosimilar is to the decision-making bodies
    • Specific regulation for biosimilars on national and regional levels
    • Bringing together communities to improve the development manufacture and commercialisation of biosimilars

    Biosimilars in Middle East: an overview

    • Defining biosimilars
    • Underline Regulatory guidelines in the Middle East
    • List Biosimilar approvals in the Middle East

    Post-market assessment of biosimilars

    •     Hear first-hand experience of evaluating the use and benefit-risk profile of biosimilars through an Italian healthcare database network
    •     What have been some of the challenges to do with data sources and methodology?
    •     What can be learnt on the effects of switching from this research?

    Biosimilar development in emerging markets

    • Regulatory landscape for biosimilar development in emerging markets
    • Reference Medicinal Product
    • Dossier expectation: EU vs. Emerging markets
    • Factors impacting timelines
    • Supply chain issues
    Parminder Kaur, CEO, RegPak BioPharma Consulting

    Biosimilars: differentiate or die

    • Differentiate through understanding customer’s experiences
    • Create an emotional connection to support future growth
    • Can biosimilars be loved long term?

    Closing remarks from the chair: Parminder Kaur, CEO, RegPak BioPharma


    Closing remarks from the chair: Gianluca Trifirò, Department of Biomedical Sciences, Dentistry and Morphological and Functional Images, University of Messina – Italy


    Offsite networking drinks reception

    last published: 09/Oct/17 13:35 GMT