SMi Group's 10th annual Biosimilars 2019 conference returns to London this September

1. www.biosimilars-europe.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Copthorne Tara Hotel, London, UK
SMi Group Proudly Present the 10th Annual Leading Conference…
WORKSHOPS: 24TH
CONFERENCE:
25TH - 26TH
SEPT
2019
Biosimilarsforecasting future regulatory, commercial & legal
challenges to advance biosimilars uptake
SMi Pharma
@SMiPharm
#SMiBiosimilars
PluS tWO intERaCtiVE half Day PRE COnfEREnCE WORkShOPS
tuESDay 24th SEPtEMBER 2019, COPthORnE taRa hOtEl, lOnDOn, uk
a: uS-fDa interchangeability Guideline
Workshop Leader:
Michel Mikhail, International Expert Regulatory Affairs,
Global Expert Biosimilars
8.30 - 12.30
B: advancing biosimilars development and uptake in
MEna and GCC regions
Workshop Leader:
Rodeina Challand, General Manager,
Challand Biosimilar Consulting
13.30 - 17.30
hiGhliGhtS fOR 2019:
• DiSCuSS the possible changes in regulatory approval of
biosimilars in the UK post Brexit, and how this will impact
market entry with the MhRa
• hEaR about current strategies under development to
overcome challenges with patents currently faced by
many biosimilar developers with Bristows llP
• EXPlORE the commercialization uptake in the China
market with BiO-thERa SOlutiOnS
• REViEW the recently approved drug delivery systems for
biosimilars with nOVaRtiS
ChaiR fOR 2019:
Michel Mikhail, International Expert Regulatory Affairs,
Global Expert Biosimilars
fEatuRED 2019 SPEakERS inCluDE:
• anne Cook, Biologicals Quality Assessor,
Medicines & healthcare Products Regulatory agency
• Dan Cohen, Regional Senior European Director Biosimilars,
Biogen
• louis Boon, CSO, Bioceros
• Steiner Madsen, Medical Director, norwegian Medicines
agency
• Corinna Sonderegger, Head Device Portfolio Biosimilars,
novartis
• aurelio arias, Senior Thought Leadership Consultant, iQVia
BOOk By 30th aPRil anD SaVE £400
BOOk By 31St May anD SaVE £300
BOOk By thE 28th JunE anD SaVE £200

2. 08.30 Registration and Coffee
09.00 Chairman’s Opening Remarks
Michel Mikhail, International Expert in Regulatory Affairs,
Global Expert in Biosimilars
Sustainability of the Biosimilars Market
KEYNOTE ADDRESS
09.10 Commercializing biosimilars - mastery or mystery?
• Variation in needs and market dynamics of biosimilar
uptake across Europe
• Biogen’s navigation within this with a focus 3 different
European markets: UK, Ireland Netherlands
• Successes and challenges Biogen have faced to date
• What’s next – how to engage and accelerate biosimilar
progress
Dan Cohen, Regional Senior European Director Biosimilars,
Biogen
09.50 Past, Present and Future outlook for Biosimilars
• Drivers for global uptake and free market dynamics
• Patients first: Successful defence strategies
• Maintaining a sustainable biosimilars market
Aurelio Auris, Senior Thought Leadership Consultant, IQVIA
10.30 Morning Coffee
11.00 The first monoclonal antibody manufactured with a fully
continuous biomanufacturing process that enters phase I studies
• Insight into the development of BiosanaPharma’s biosimilar
Omalizumab
• Explaining the cost-saving advantages of this innovative
manufacturing process
• Overview of the non-clinical studies prior to phase 1 clinical
trial approval without any animal studies
Jaap Wieling, CSO, Biosana Pharma
INTERNATIONAL ADDRESS - AUSTRALIA
11.40 Australia and the flow in payer-driven distribution
• Just as biologics are not chemicals so there is a need for
new business models for biosimilars
• Substitution of biosimilars is not the same as supervised
clinical switching
• Biosimilar pharmas payers underestimate Patients,
Prescribers and Pharmacists at their risk
• The key to access is confidence not cost
Stephen Murby, Board Member International Advisory Council,
Alliance for Safe Biologic Medicines (ASBM)
12.20 Networking Lunch
Understanding the regulatory framework
for biosimilar approval
13.20 Indication of the MHRA’s decision making regarding biosimilar
approval
• Insight into the new assessment procedures being offered,
including the involvement of the EMA (European Medicines
Agency)
• Current difficulties in determining efficacy and safety of
biosimilars
• Exploring the future obstacles that will prevent approved
biosimilars from reaching the market
Anne Cook, Biologicals Quality Assessor, MHRA
14.00 Barriers behind the development and uptake of biosimilars in
the US
• Understanding why the US’s regulatory machinery has
caught up with the approval of several biosimilars, yet only
a few have been launched
• Evaluation of the impact this predicament has in terms of
starving the public from access to affordable healthcare
• American features of the biosimilar market include
late development of guidelines, patient litigations,
interchangeability regulation and lack of systematic effort in
educating physicians and patients
• What are policy makers doing to encourage uptake?
Rodeina Challand, General Manager, Challand Biosimilar
Consulting
14.40 Afternoon Tea
INTERNATIONAL ADDRESS - CHINA
15.10 Exploring the regulatory environment for biosimilars in China
• Discussing the recent changes in the regulatory polices of
biosimilars
• Overview on the evolution of biosimilar development in
China
• Understanding the significant impact of the regulatory
changes and how they affect biosimilar development
• Updates on biosimilar market in China
Bert Thomas, Senior Vice President Business Development,
Bio-Thera Solutions
15.50 Evaluating biosimilar market access policies in EU and
degrees of success
• Why is policy important for the success of biosimilars?
• What are countries’ approaches to biosimilars; do they
embrace them?
• Why are some countries more successful than others?
• Review of how updated guidelines have included
biosimilars, and where gaps remain
Sue Naeyaert, Market Access Policy Expert,
International Consultant Biosimilars
16.30 Chairman’s Closing Remarks and Close of Day One
Michel Mikhail, International Expert in Regulatory Affairs,
Global Expert in Biosimilars
Biosimilars
Day One | Wednesday 25th September 2019 www.biosimilars-europe.com
Register online at www.biosimilars-europe.com

3. 08.30 Registration and Coffee
09.00 Chairman’s Opening Remarks
Michel Mikhail, International Expert in Regulatory Affairs,
Global Expert in Biosimilars
OPENING ADDRESS
09.10 How to make biosimilars a future reliable source?
• Addressing the importance of patients’ interest
• Impact of loss of biosimilar market on pricing
• Commercial advantages of rise in biosimilar market
to originator companies
• Discounting of biosimilars – benefits and drawbacks
Steinar Madsen, Medical Director, Norwegian Medicines
Agency
09.50 POST-BREXIT PANEL DISCUSSION: Concerns with the possible
changes in regulations of biosimilars in the UK post Brexit
• Debating how Brexit would impact the launch of
forthcoming biosimilar drugs in the UK market
• Major setback of approval – possible need of
2nd approval from MHRA
• Risks of some biosimilar manufacturing companies
skipping the UK all together due to extensive costs
• Hindering of the cost cutting approach of the NHS
Moderator
Michel Mikhail, International Expert in Regulatory Affairs,
Global Expert in Biosimilars
Panel Members
Anne Cook, Biologicals Quality Assessor, Medicines
Healthcare Products Regulatory Agency
Liz Pollitt, Director, BPCRCS
10.30 Morning Coffee
Overcoming legal issues with patent protection
11.00 Current updates in patent protection costs – how will this
impact the biosimilars market
• A review of biosimilars litigation date
• Introduction of Arrow Declarations – newly developed
mechanism overriding the secondary patents currently
protecting key originator biologic products.
• Case study on Humira: first drug to be granted arrow
declaration
• Settlement Agreements – is it safe to go back into water?
Dominic Adair, Partner, Bristow’s LLP
11.40 Patent protection – the international perspective
• Multi-dimensional chess - multiple patents, multiple owners,
multiple countries
• Resolution and settlement of biosimilars patent litigation to
date
• A new system – the UPC or ADR?
Christopher Stothers, Partner, Freshfields Bruckhaus Deringer
12.20 Networking Lunch
Bridging the gap between pharmaceutical companies,
patients and investors
13.20 Biosimilars: Reframing communications and changing
behaviours
• Overview of the progress of Infliximab biosimilars following
their launch
• Role of Medical Affairs and Medical Communications
• What’s next? biosimilars as an incentive for innovation
Christian Agbotanm, Senior Medical Brand Director, Takeda
Pharmaceuticals
KEYNOTE ADDRESS
14.00 Drug Delivery Systems for Biosimilars – Copy or Innovate
• Regulatory requirements and opportunities to differentiate
• Formulation and Container Closure System – case studies
with challenging proteins
• Injection Devices – understanding, predicting and aligning
different customer needs for a truly competitive product
design
Corinna Sonderegger, Head Device Portfolio Biosimilars,
Novartis
14.40 Afternoon Tea
15.10 Using SPOT™ and SLIM™ technology and upstream process
modulation to reduce cost of goods of biosimilars
• Increase specific productivity using SPOT™
• Increase specific productivity and biosimilar product quality
using upstream process modulation
• Reduce process issues using SLIM™
• Reducing cost of goods of biosimilars
Louis Boon, CSO, Bioceros
15.50 Assuring the Quality of Biosimilars through International
Standards
• Focus on maintaining the quality of biosimilars following its
authorization
• The role of WHO standards of biological activity in
maintaining potency
• Current Developments in International Standards
Meenu Wadhwa, Section Leader Cytokines Growth Factors,
National Institute for Biological Standards and Control
16.30 Chairman’s Closing Remarks and Close of Day Two
Michel Mikhail, International Expert in Regulatory Affairs,
Global Expert in Biosimilars
Biosimilars
www.biosimilars-europe.com Day Two | Thursday 26th September 2019
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

4. US-FDA Interchangeability Guideline
Workshop Leader: Michel Mikhail, International Expert Regulatory Affairs, Global Expert of Biosimilars
Workshop Overview:
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was
enacted on March 23, 2010. The BPCI Act created an abbreviated licensure
pathway for biological products shown to be biosimilar to or interchangeable
with an FDA-licensed reference product. “Interchangeability” means that the
biological product may be substituted by the dispensing Pharmacist for the
reference product without the intervention of the health care provider / Physician
who prescribed the reference product. This automatic substitution by the
pharmacist allows reducing the health care cost and allows wider access of more
patients to these high quality medicinal products.
Why should you attend:
The Workshop will address the Regulatory requirement of the US-FDA Guidance
to Industry entitled: “Considerations in Demonstrating Interchangeability With
a Reference Product” published in January 2017 and setting the details of the
clinical study needed to demonstrate that interchangeability leads to the same
clinical outcome in any given patient with no increased safety - or decreased
efficacy concerns.
About the Workshop Leader:
Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry
experience and track record of achievement in R D and International
RegulatoryAffairsinlargemultinationalResearch-basedpharmaceutical
Companies, Biotech Companies as well as in the Generics industry. He
is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical
Expert as well as a chartered Analytical Expert. Dr. Mikhail is a Global Expert in
Biosimilars and International Regulatory* Affairs Expert. He served as member of
the Expert committee of the Government Federal Institute of Risk Assessment (BfR)
Germany and served as member of the Expert Committee for Toxicology of the
United States Pharmacopoeia (USP).
HALF-DAY PRE-CONFERENCE WORKSHOP A
Tuesday 24th September 2019, Copthorne Tara Hotel, London, UK | 08.30 – 12.30
HALF-DAY PRE-CONFERENCE WORKSHOP B
Tuesday 25th September 2019, Copthorne Tara Hotel, London, UK | 13.30 – 17.30
Advancing Biosimilar development and uptake in MENA GCC regions
Workshop Leader: Rodeina Challand, General Manager, Challand Biosimilar Consulting
Workshop Overview:
The need for biologics is critical in this region but the cost of these products are
inhibiting uptake of biologics which is estimated at 2% of drugs used compared
to 45% in the US. The workshop will highlight the challenges and address how we
can support this region.
Why should you attend:
This workshop is targeted to professionals working in these specific sectors of the
biosimilars industry: Research Development, Regulatory, Business Development,
Clinical Operations etc. However, attendees who are interested in hearing about
current strategies being implemented to improve biosimilar uptake outside the EU
and USA are more than welcome.
About the Workshop Leader:
Rodeina Challand is a Science and Law Graduate with 30 years of
experience in healthcare, cancer research, pharmaceutical industry
and CRO, across a wide range of roles including developing and
implementing clinical development strategies for biosimilars and
complex generics. Experience in all aspects of biosimilar development
including study design and regulatory agency discussions (EMA, FDA, MENA,
GCC, Australia, India, Japan and S. Korea). In the last few years have worked
with the developing regions and conducted several meetings with MENA and
GCC Regulatory Agencies to educate and better understand their expectations
licensing biosimilars; also supporting them in implementing clinical trial regulations
and educating potential investigators in the region. Worked on over 15 biosimilar
molecules across a range of products and indications, including ESAs, Filgrastims,
Heparins, Insulins and monoclonal antibodies in various capacity including
consulting, regulatory and clinical strategies, feasibility and supporting study
delivery across all phase of development (phase I to IV).
Register online at www.biosimilars-europe.com
Agenda:
08.30 Registration Coffee
09.00 Workshop leader introduction
09.10 Analytical Fingerprint-like similarity is the
foundation for approval of Biosimilars
09.50 Two-step approval Process by the
US-FDA
10.30 Morning Coffee Networking Break
11.00 The use of post-marketing data from a marketed
biosimilar in the USA
11.45 The use clinical data to demonstrate switching
risk in all of the reference biologic’s licensed
conditions of use
12.20 Workshop leader closing remarks
12.30 Close of workshop
Agenda:
13.30 Registration Coffee
14.00 Workshop leader introduction
14.10 Experience in using biologics
• Biologic use in these regions is the lowest in the
world. Arising discussion on why this is the case
14.50 Regulatory status country by country
• Issues surrounding this include the lack of
expertise in assessing licensing applications, and
the lack of robust pharmacovigilance systems
15.30 Afternoon Tea Networking Break
16.00 Relative isolation of Arab physicians from the
rapidly developing world
• Highlighting the causes of this, including the lack
of expertise in assessing license applications,
and the need for local analytical testing
16.45 Opportunities available for biosimilars in MENA
and GCC regions
• The need for biosimilars is critical. Diabetics and
cancer are prevalent across the region, with
some of the highest prevalence globally
17.20 Workshop leader closing remarks
17.30 Close of workshop

5. SMi PhaRMaCEutiCal
EVEnt PlannER 2019
May 2019
Pain therapeutics
13th - 14th May 2019, London, UK
highly Potent active Pharmaceutical ingredients
13th - 14th May 2019, London, UK
injectable Drug Delivery
15th - 16th May 2019, London, UK
JunE 2019
PrefilledSyringesWestCoast
3rd - 4th June 2019, San Diego, USA
lyophilisation
3rd - 4th June 2019, London, UK
Pharmaceutical Microbiology West Coast
5th - 6th June 2019, San Diego, USA
SEPtEMBER 2019
BioBanking
25th - 26th September 2019, London, UK
Biosimilars
25th - 26th September 2019, London, UK
OCtOBER 2019
Wearable injectors and Connected Devices
9th - 10th October 2019, London, UK
Cleanroom technology
9th - 10th October 2019, London, UK
Orphan Drugs Rare Diseases
15th - 16th October 2019, London, UK
highly Potent active Pharmaceutical ingredients uSa
21st - 22nd October 2019, Boston, USA
lyophilization uSa
23rd - 24th October 2019, Boston, USA
nOVEMBER 2019
Respiratory Drug Delivery
13th - 14th November 2019, London, UK
Ophthalmic Drugs
18th - 19th November 2019, London, UK
Workshop Leader:
William k. Schmidt, President,
northStar Consulting, llC
Biosimilars
www.biosimilars-europe.com
MaRkEtinG PaRtnERShiP OPPORtunitiES
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to your industry. Should you wish tojointheincreasingnumberofcompaniesbenefitingfromsponsoringourconferencespleasecall:
alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Register online at www.biosimilars-europe.com
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LETTER FROM THE CHAIR
Dear Colleagues,
As the chairman of the 2019 event and on behalf of SMi Group, I am delighted
to cordially invite you to our 10th Biosimilars Conference taking place on the 25th
and 26th September 2019 in London, UK. We have prepared a very interesting
programme. This year’s event will address regulatory issues, alongside case
reports of developing, forecasting launching the next wave of biosimilars to
ensure optimal uptake and successful commercialization of these high quality
medicinal products.
This year’s Biosimilars Conference will kick-off on tuesday 24th September with two
pre-conference half-day workshops: one on “interchangeability of Biosimilars
in the uSa: the uS-fDa Regulatory Guidance”, in the morning and, the other
on “advancing biosimilars development and uptake in MEna and GCC regions”
in the afternoon.
After over a decade of successful experience with biosimilars in Europe, the
biosimilars industry is fi nally reaching a stage where key stakeholders better
understand and accept biosimilars. This is refl ected in the requirements for
development, regulatory approval post-marketing surveillance and an
increased uptake of biosimilars across the globe.
We are now entering a very exciting time, for over the next few years several
originator patents are expiring, and we will see the next few waves of biosimilars
enter the market. Will the biosimilar be a successful contender and spark a
competitive environment or the originator dominate? Have we done enough to
convince the payer, prescriber and patient to switch?
Join us to hear experiences of prominent speakers key opinion leaders and
evaluate market access, opportunities and commercialization strategies with
industry-thought experts.
To view the full details of the 2-day conference agenda, half-day workshops and
the expert speaker line-up, please see the brochure enclosed.
We look forward to welcoming you at the conference in London.
Michel Mikhail,
International Expert in Regulatory Affairs,
Global Expert in Biosimilars

6. BiOSiMilaRS 2019
Conference: Wednesday 25th Thursday 26th September 2019, Copthorne Tara Hotel, London, UK
Workshops: Tuesday 24th September 2019, Copthorne Tara Hotel, London, UK
4 WayS tO REGiStER
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