08.30 Registration and Coffee

09.00 Chairman’s Opening Remarks Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

MARKET ANALYSIS

OPENING ADDRESS09.10 After more than a decade of Biosimilars in Europe – how will

the markets change over the next couple of years?• Historical Background about Biosimilars from 2006 until now• Claims and Assumptions during the fi rst years• Differences in the acceptance of Biosimilars between US

and Europe – how come?• Biosimilars of Avastin®, Herceptin® and Humira® will enter

the European markets in 2018/2019 – what can we expect? Michael Muenzberg, Member, Comparative Outcomes Group and Former EU Medical Director, Biosimilars, Amgen

KEYNOTE ADDRESS09.50 Sustainability, affordability and expanded patient access:

The keys to ensuring biosimilar success in Europe• Success for biosimilars involves delivering a positive impact

today, but also continuously over time• Policy changes and widespread adoption will be critical

to expand access and get these products in the hands ofpatients

• Biosimilars must be viewed through a lens that goes beyondprice, and includes overall affordability and sustained value

Paul Harmon, Senior Director Oncology Biosimilars, Mylan

10.30 Morning Coffee

11.00 Session Reserved for Impact Medical Education

11.40 Session Reserved for Sandoz • Session points to be confi rmed Christian Naumann, Head of Global Marketing Biopharmaceuticals, Sandoz

12.20 Networking Lunch

MARKET ACCESS & COMMERCIALISATION

CASE STUDY13.40 Biosimilar development in a mid-size pharma

environment - the pegfi lgrastim case at Cinfa Biotech• Case study example of pegfi lgrastim biosimilar

clinical trial design• Understanding how we can build a bridge between the

originator and biosimilar product using a specifi c, consistentand tailor-made approach

• The importance of study population, study design, endpointsand statistics

• Collaborating with regulatory affairs and making clinicalstudies as sensitive to differences as possible

Rüdiger Jankowsky, Managing Director, Cinfa Biotech

CASE STUDY14.10 Challenges in coming to market with an

etanercept biosimilar• Changes in the competitive environment• Biosimilar market trends• Uptake of biosimilars in different European countries• Regulatory requirements in different countries impact

biosimilar uptake• Go-to-market considerations Richard Peck, Vice President Regulatory Affairs, Lupin (Europe) Ltd

14.50 Afternoon Tea

15.20 Payer perspectives on value drivers for biosimilars • Healthcare Fiscal overview and medicines funding

landscape for Biosimilars• New NHS CQUINs on Biosimilars and how payers are

implementing this• How Payers are aligning biosimilars with innovative parent

brands to streamline patient care settings• Physician loyalty [brand v biosimilar and biosimilar v

biosimilar] and how this affects formulary uptake• What value offerings from biosimilars resonate with payers

and formulary decison makers• Drivers for outcomes based, innovative contracting for new

medicines• Bridging the ‘uncertainty gap’ between payers & pharma -

the shifting paradigm Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University of Portsmouth

16.00 When perceptions matter... addressing the NOCEBO effect• Expanded use of generics and now the increasing use

of Biosimilars have brought the NOCEBO effect to theattention of clinicians.

• NOCEBO describes the correlation between negativeexpectations or negative communications with negativesubjective treatment outcomes

• NOCEBO can cause the induction or the worsening ofsymptoms by sham or active therapies and may accountfor some adverse events (AEs) reported by patientsfollowing treatment , additionally it can have an effect onthe adherence on Biosimilars

• Proper fact-based explanations by health care professionalscoupled with strategies to reassure and engage patientsupon initiating or switching to a biosimilar are key in ensuringbetter treatment outcomes and sustainability on Biosimilars

Mourad Farouk Rezk, Global Head Medical Affairs Biosimilars, Biogen

16.40 Do we really need clinical trials for a biosimilar?• What is the medico-scientifi c question?• Revisiting David Sackett (EBM)• Different stakeholders hold different perspectives• Is there an ethical dilemma?• Disagreeing agreeably Uwe Gudat, Head of Clinical Safety & Pharmacovigilance, Fresenius-Kabi

17.20 Chairman’s Closing Remarks and Close of Day One Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

BIOSIMILARS AND BIOBETTERS Day One | Wednesday 26th September 2018

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Register online at www.biosimilars-europe.com

08.30 Registration and Coffee

09.00 Chairman’s Opening Remarks Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

UPDATES TO REGULATIONS AND GLOBAL STANDARDS

OPENING ADDRESS09.10 Towards sustainability and harmonisation of biosimilars

through WHO international standards• The concept of international standardisation• Setting new standards: WHO international standards for

monoclonal antibodies• Future plans for WHO standards for biosimilars and

immunogenicity testing Meenu Wadhwa, Head, Cytokines & Growth Factors, Biotherapeutics Group, National Institute for Biological Standards and Control

09.50 US-FDA interchangeability Guidance - what is needed to obtain the Interchangeable status for the Biosimilar product• Learn the latest FDA regulatory changes towards

interchangeability of biosimilars• Evaluation of biosimilars in the race to obtaining this status• First in line: Recommendations on how to achieve

interchangeability• Discuss what will need to be done after accomplishing this

to increase biosimilar uptake in patients, physicians andprescribers’ groups

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

10.30 Morning Coffee

MARKET OPPORTUNITIES

SPOTLIGHT PRESENTATION11.00 Increasing market opportunities in China

• Review the latest regulatory updates in China• Hear how these changes increase market

opportunities for companies across the globeto sell in China

• Determine how to optimise Chinas growing ability to payDaotian Fu, General Manager, Livzon Mabpharma

11.40 Biosimilar orphan drugs• The value of Orphan drugs• Why we need biosimilar orphan drugs• How do we show similarity?• What will the regulators expect? Rodeina Challand, General Manager, Challand Biosimilar Consulting

12.20 Networking Lunch

13.30 Lessons from the front line; launching biosimilars in Europe• Biosimilar uptake in the EU• The heterogeneity of European health economies• Experience from 3x mAb biosimilar launches in EU• Essentials of procurement• Long term sustainability of the European biosimilar marketPhilippe Bastide, Head of Biosimilars, Mundipharma

SPOTLIGHT PRESENTATION14.10 The importance of analytical and pharmacological

data for the biosimilar development• Timing of method availability during the biosimilar

development program• Tiering of quality attributes and the respective needs for

analytics• Requirements for analytical and pharmacological

methodologies to comply with regulatory expectations• The importance of structure function relationship knowledge Niklas Czeloth, Head of Biosciences Biosimilars, Boehringer Ingelheim

14.50 Afternoon Tea

SPOTLIGHT PRESENTATION15.20 Designing and conducting clinical trials

for biosimilars• Clinical trial development for Biosimilars: present

and future• Clinical operational challenges• Best operational procedures to minimize cost and maximize

result Ekkehard Brockstedt, Team Leader Outsourced Trials, Boehringer Ingelheim

16.00 Optimising biosimilar uptake• With several biosimilars in the market, what lessons can we

learn on subsequent launches?• Which countries provide a good environment for a biosimilar

launch?• What levers does a manufacturer have to promote

successful uptake?• What should be considered in creating an ideal commercial

model?Aurelio Arias, Senior Thought Leadership Consultant, Iqvia

16.40 Experiences of delivering biosimilar medicine studies in a national health service• Case study examples of initiating biosimilar medicine trials in

the NHS• Implementing solutions to unique challenges• Adopting the network approach to site selection• Increasing clinical confi dence through education Divya Chadha Manek, Head of Business Development Commercial, National Institute for Health Research

17.20 Chairman’s Closing Remarks and Close of Day Two Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

BIOSIMILARS AND BIOBETTERS Day Two | Thursday 27th September 2018

BIOSIMILARS AND BIOBETTERSDay One | Wednesday 26th September 2018 www.biosimilars-europe.com

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Global Development of Biosimilars: A Refresher

Workshop Leader: Michel Mikhail,

Global Expert in Biosimilars

Workshop Overview: This workshop aims to refresh delegates involved in the development of biosimilars with essential knowledge and will provide a fantastic introduction for beginners entering biosimilar development. The workshop will cover some aspects of the all-important chemistry, manufacturing and controls (CMC) for dossier for analytical similarity, non-clinical and clinical development, and regulatory requirements in the EU and the US, including the two-step approval process in the US.

Why should you attend this workshop: • Expand your knowledge on how best to develop

biosimilars in a global market• Equip yourself with expert knowledge of how to

approach development in order to maximize market approval potential

• Fantastic interactive platform for delegates to share industry experience and hear from an international expert in the field

Agenda:

08.30 Registration & Coffee 09.00 Workshop leader introduction 09.10 Analytical similarity form the basis of the CMC

dossier • Choice of reference product • Batch to batch variability of the reference

product • Representative biosimilar batch to be used in

the clinical development 09.50 Non-clinical development and clinical

development of biosimilars • The 3R concept: Replacement, reduction and

refinement • In-vitro pre-clinical similarities vs. in-vivo animal

studies • Phase 1 and phase 3 clinical development 10.40 Morning Coffee and Networking Break 11.10 EU vs US regulatory requirements • Using US reference product for the global EU

and US development of biosimilars • Bridging studies vs. EU reference product • Cost of reference product vs availability,

blinding aspects

11.50 Two-step approval in the US • First step as a biosimilar • Second step as an interchangeable biosimilar • An introduction to the FDA interchangeability

guidelines 12.30 Close of workshop

About the Workshop Leader: Michel Mikhail, Global Expert in Biosimilars

Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and

International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines.

HALF-DAY PRE-CONFERENCE WORKSHOP ATuesday 25th September 2018

Copthorne Tara Hotel, Central London, UK 08.30 – 12.30

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Value Based Agreements with Biosimilars: Architecture of Value Based Agreements

Workshop Leader: Omar Ali, Visiting Lecturer Value Based Pricing, University of Portsmouth & Former Adviser, NICE

Workshop Overview: The workshop aims to provide an insight into development and deployment of Value Based Agreements [outcomes based innovative contracting] with regards to biological and biosimilar therapies. Summary overview of global examples, with analysis and construction of such agreements. Review of payer archetypes and internal Pharma VBA readiness and deployment of VBA agreements.

Why should you attend this workshop: • Interest in value based agreements • Analysis of value based agreements with biosimilars• Construct of value based agreements• Use of risk sharing within pharmaceuticals

Agenda:

13.30 Registration and Coffee

14.00 Workshop leader introduction

14.10 Case examples of value-based agreements with biological & biosimilar products

14.40 Analysis of market access and payer perspectives

15.10 Afternoon Tea and Networking Break

15.40 Construction of value-based agreements

16.10 “How ugly is my child “ – assessing value & innovation

16.30 VBA Levers in construction of risk sharing

16.50 Assessing and evaluating payer archetypes for VBA

17.10 Internal VBA readiness and deployment of VBA

17.30 Close of workshop

About the Workshop Leader: Omar Ali, Visiting Lecturer Value Based Pricing, University of Portsmouth & Former Adviser, NICE

Qualified with a hospital pharmacy background, Omar has been working as the Formulary

Advisor for Surrey & Sussex Healthcare NHS Trust for over 15 years, sitting on the regional Joint Drugs & Therapeutics Committee as well as the CCG/Commissioning Prescribing Clinical Network. He is currently a Visiting Lecturer at University of Portsmouth School of Pharmacy and Biomedical Sciences.

Omar has served a position on the External Reference Group on Cost Impact Modelling for NICE for 6 years and was subsequently appointed Panel Member for the newly formed Adoption & Impact Program Reference for NICE. and advises foreign investors (US Embassy) on ‘Value Based Assessments (hosted by the UK Department of Trade & Industry).

Last year he was invited to address the Italian Healthcare Senate [Senato della Repubblica] on Pharmaco-economic Evaluation & Sustainability Models of Healthcare and featured at the Westminster Health Forum Keynote Seminars [chaired by Lord Howe, All Party Parliamentary Group on Pharmacy] on the Future for Pharmacy Commissioning, Organisation & Delivery. At this current time he has embarked on a PhD with his doctorate thesis entitled “Value Based Pricing & Outcomes Based, Innovative Contracting of New Medicines”.

HALF-DAY PRE-CONFERENCE WORKSHOP BTuesday 25th September 2018

Copthorne Tara Hotel, Central London, UK 13.30 – 17.30

www.asdevents.com - www.asdevents.com/event.asp?id=18847