www.biosimilars-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

SMi Group presents the 5th Annual Conference on… WORKSHOPS: 13TH

CONFERENCE: 14TH - 15TH

NOV 2018

Biosimilars USA Developments in Biosimilar Drug Development

SMi Pharma

@SMiPharm

#SMiBioSimUSA

BOOK BY 28TH SEPTEMBER TO SAVE $100

HIGHLIGHTS IN 2018:

• Assess which biosimilars should be kept in your pipeline

• Discuss a switching literature review from Sandoz

• Explore routes to take if your biosimilar has a better formulation and/or administration than the originator

• Examine FDA guidance on biosimilars to expedite approvals and acceptance

• Learn how to meet high GMP compliance when manufacturing outside of the US

• Thoroughly assess partners biosimilar programs for in licensing

• Discover alternative expression systems for production of biosimilars and biobetters

CHAIR FOR 2018:• Richard DiCicco, Chairman,

Harvest Moon Pharmaceuticals USA

FEATURED SPEAKERS:• Christina Yunis, Global Biosimilars Market Development

Lead, Pfizer Essential Health• Houng Kim, Head of Strategy and Operations

Division, Celltrion Healthcare • Hillel Cohen, Executive Director, Scientific Affairs, Sandoz • Nigel Rulewski, Vice President, Head Biosimilar

Center of Excellence, IQVIA • Don Stewart, CEO, PlantForm Corp • Arun Nataraj, Senior Director, Business Development

& Corporate Strategy, Amneal Pharmaceuticals

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSTuesday 13th November 2018, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Workshop B: Dealing with Life Sciences Patents at the PTAB

Workshop Leaders: Ha Kung Wong, Partner, New York, Fitzpatrick, Cella, Harpper & ScintoJohn Kirkland, Director, Intellectual Property, Alkermes, Inc.

13.30 - 17.30

Workshop A: Decoding How Stakeholders May Drive Biosimilar Adoption

Workshop Leaders: Tucker Herbert, Manager, ZS Associates

Christina Corridon, Associate Principal, ZS Associates08.30 - 12.30

Register online at www.biosimilars-usa.com

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.

Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director, on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

08.30 Registration and Coffee

09.00 Chairman’s Opening Remarks Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

OPENING KEYNOTE PRESENTATION09.10 Sustainability is key to realizing the benefit biosimilars offer to patients, physicians, payers and healthcare systems

• Biosimilars is a very dynamic market and not only from a competitive environment perspective, but the Intellectual Property (IP), Policy and Regulatory Environment will continue to evolve

• There are 5 main ingredients to achieving a vibrant, sustainable environment for biosimilars that benefits patients, healthcare systems and industry:

- Fair and early access to market, - Appropriate pricing, - Biosimilars from several competitors on the market, - Broad insurance coverage, and - Educated and supportive physicians and patients• As an industry, we must unite to ensure health systems are ready to

realise the potential of biosimilars in the US, and around the world Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

Essential Health

UPDATES TO THE US BIOSIMILAR LANDSCAPE, REGULATIONS AND PATENT LITIGATIONS

09.50 New Dance Moves: How recent caselaw has reshaped the BPCIA patent dance• A discussion looking at several of the recent US case law rulings that

have significantly altered the canonical timeline for BPCIA litigation, and how biosimilars makers can potentially navigate those changes

• A discussion on how the Amgen v. Sandoz Supreme Court case has opened the door to bypassing the patent dance and accelerating the time period for pre-launch declaratory judgment litigation

• A discussion on the potential for pre-launch damages litigation, as were awarded in the Amgen v. Hospira district court decision

• A discussion on how, whether and when to disclose biosimilar manufacturing info, as was the subject of the Amgen v. Hospira Fed Cir decision

• A discussion on the recent skirmishes in California over choice of venue, as in the pending Amgen v. Genentech and Celltrion v. Genentech matters

• A discussion of the FDA’s process for approving biosimilar applications, and how the FDA’s approval timeline syncs up (or does not) with the BPCIA’s “expected” litigation timeline

Christopher Loh, Partner, FITZPATRICK, CELLA, HARPER & SCINTO Peter Waibel, Head of US Patent Litigation, Novartis

10.30 Morning Coffee

11.00 Recent Expected and Unexpected Developments in Biosimilar Drug Development• US interchangeability requirements in the US • Use of Next Generational Tools and novel paradigms to accelerate

the clinical development cycle• Steps that innovator companies have taken to block biosimilar

development• Steps being taken to erode the “patent dance” in the US• The potential for using a global reference comparator• The possibility of abbreviating the biosimilar development pathway• The emergence and ramifications of the ‘Nocebo Effect’Nigel Rulewski, Vice President Strategic Drug Development, Head Biosimilar Center of Excellence, IQVIA

SPOTLIGHT PRESENTATION11.40 The future of biosimilars and its roles • Who are we? • Physicians’ perspective on early introduction of biologics • The future and role of biosimilars • Reducing cost and increase patient access Houng Kim, Head of Strategy & Operations Division, Celltrion Healthcare

12.20 Networking Lunch

13.20 Do biosimilars really need Real World Evidence?• What is Real World Evidence (RWE) and how is this different to trial data?• Recent trends in RWE: standards and regulatory inclusion• What does this mean for your market access issues? • Looking at ways to use RWE innovatively during development

Anita Burrell, Principal, Anita Burrell Consulting

KEYNOTE PRESENTATION14.00 Rationalising FDA guidance on Biosimilars - Expediting approvals and acceptance

• FDA to eliminate bridging test, make statistical equivalence criteria clinically relevant and allow in vitro immunogenicity where available

• The FDA, the prescribers and the payers jointly promote the use of biosimilars as first choice for new patients, given that there is no clinically meaningful difference

• The developers to concentrate on fingerprint like similarity rather than offering to do studies in patients

Sarfaraz Niazi, Founder, Karyo Biologics, LLC

14.40 Afternoon Tea

SWITCHING AND INTERCHANGABILITY

15.10 Switching form Reference Biologics to Biosimilars• Scientific literature was reviewed from 1993 to

June 30, 2017 to identify publications that described switching from reference biologic to a biosimilar

• Ninety studies were identified, involving 7 molecules used to treat 14 disease indications, enrolling a total of 14,225 individuals• The great majority of studies did not report differences in safety,

efficacy or immunogenicity• The results suggest a low risk of either a safety concern or loss of

efficacy after switching to a biosimilarHillel Cohen, Executive Director, Scientific Affairs, Sandoz

PANEL DISCUSSION:15.50 How sustainable is the biosimilars market?

• Where is the market heading?• Who will be the relevant players and where will they be based globally?• Will we see a migration of manufactures to low cost countries as we

did with generics?• What are the short and long-term gains?• In 10 years’ time, will there still be a market that can make profit?Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc. Anita Burrell, Founder and CEO, Anita Burrell Consulting Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

16.30 Chairman’s Closing Remarks and Close of Day One

BIOSIMILARS USA Day One | Wednesday 14th November 2018 www.biosimilars-usa.com

SEPTEMBER 2018

Biosimilars & Biobetters26 - 27 September, London, UK

Immuno-Oncology26 - 27 September, London, UK

OCTOBER 2018

Cell & Gene Therapy10 - 11 October , London, UK

Orphan Drugs & Rare Diseases 17 - 18 October, London, UK

NOVEMBER 2018

USA WEEK

Superbugs & Superdrugs USA12 - 13 November, New Jersey, USA

Biosimilars USA14 - 15 November, New Jersey, USA

Lyophilization USA15 - 16 November, New Jersey, USA

Ophthalmic Drugs26 - 27 November , London, UK

DECEMBER 2018

Cold Chain Distribution10 - 11 December, London, UK

JANUARY 2019

Pre-Filled Syringes & Injectable Drug Devices16 -17 January, London, UK

Pharmaceutical Microbiology 21 - 22 January, London, UK

Social Media in the Pharmaceutical Industry 21 - 22 January, London, UK

FEBRUARY 2019

Parallel Trade5 - 6 February, London, UK

3D Cell Culture 20 - 21 February, London, UK

RNA Therapeutics20 - 21 February, London, UK

SMI PHARMACEUTICAL EVENT PLANNER 2018/2019

Register online at www.biosimilars-usa.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

MARKETING PARTNERSHIP OPPORTUNITIESSMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile,add value,

create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering? Contact Simi Sapal, Marketing Manager on +44 (0) 20 7827 6162 or email: ssapal@smi-online.co.uk

WE ARE PROUD TO BE PARTNERS WITH:

08.30 Registration and Coffee

09.00 Chairman’s Opening RemarksRichard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

KEYNOTE ADDRESS09.10 Which biosimilars should you include in your pipeline?

• Do you target the emerging market first? • Considerations and strategies when choosing which biosimilar to

include in your pipeline• Venturing out of monoclonal antibody biosimilars Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

MANUFACTURING CONSIDERATIONS

SPOTLIGHT PRESENTATION 09.50 Alternative expression systems for production

of biosimilars and biobetters • Drug production using plant based and other

expression systems • Regulatory environment for non-traditional expression systems • Partnerships using alternative expression systems to

develop biosimilars and biobetters Don Stewart, CEO, PlantForm Corporation

10.30 Morning Coffee

11.00 In-Licensing Biosimilars: Best practices to complete diligence successfully and key contractual terms to be addressed when executing the agreement• Gap analysis in the data during due diligence and Partners plans to

address them. FDA correspondence following Pre-IND and pre-BLA meetings

• The importance of outside consultants and their role in due diligence

• Structuring a deal to de-risk your investment until there is confidence in the program

• Critical contractual issues that need to be negotiated in a favourable manner (to you)

Arun Nataraj, Senior Director, Business Development & Corporate Strategy, Amneal Pharmaceuticals

11.40 Dosage form and formulation strategy for life cycle management of biosimilars• Presentation will review formulation and dosage form

considerations for biosimilars – a review of currently approved biosimilars and their dosage forms

• Presentation will focus on one or more case studies where it is essential to re-consider formulation changes and have a strategy for life cycle management for the approved biosimilar

Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

12.20 Networking Lunch

13.20 Canadian Regulatory Perspective on Biosimilars

• Regulatory Framework – the Canadian Food and Drugs Act and

Regulations and Health Canada’s Guidance Documents on the

Information and Submission Requirements for Biosimilars

• Clinical requirements for biosimilar drug submissions

• Intersect of Patented Medicines and the approval process for

Biosimilars

• Roles of the Federal versus Provincial Jurisdictions

• Authorised/marketed Biosimilars in Canada

Catherine Soo, Senior Clinical Evaluator, Health Canada

COMMERCIALISATION AND UPTAKE

14.00 Biosimilars — can they all survive?

• Will the first biosimilar always win?

• Switching – is there a cost limit?

• From biosimilars to biosimilars in practice – problem or solution?

Steinar Madsen, Medical Director, Norwegian Medicines Agency

14.40 Afternoon Tea

15.10 A case study of development for biosimilars

• The strategy of development used

• Scientific issues encountered during development

• How the scientific issues can be circumvented in order to streamline

development

• The process of approval

Magdalena Leszczyniecka, President and CEO, STCBiologics

PANEL DISCUSSION:

15.50 Forecasting uptake of biosimilars entering the market:

Points to consider

• How can biosimilars differentiate themselves when clinical

differentiation isn’t possible? How much will manufacturing quality

and reliability of supply matter?

• What levers are the most successful at encouraging biosimilar

adoption?

• The changing balance of decision-making power across

stakeholder

Hillel Cohen, Executive Director, Scientific Affairs, Sandoz

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA

Nigel Rulewski, Vice President Strategic Drug Development, Head

Biosimilar Center of Excellence, IQVIA

16.30 Chairman’s Closing Remarks and Close of Day Two

BIOSIMILARS USA www.biosimilars-usa.com Day Two | Thursday 15th November 2018

BIOSIMILARS USA Day One | Wednesday 14th November 2018 www.biosimilars-usa.com

Supporters:Official Media Partners:

*Subject to final confirmation

Decoding How Stakeholders May Drive Biosimilar Adoption

Workshop Leaders: Tucker Herbert, Manager, ZS Associates

Christina Corridon, Associate Principal, ZS Associates

Workshop Overview: We will focus on stakeholders that will determine the success (or failure) of biosimilars as they launch in the US. We will explore their key drivers/barriers to biosimilar adoption, including subconscious biases that may favour the status quo. We’ll then discuss some innovative approaches to market research and forecasting to improve the accuracy of your future outlook in light of different landscape scenarios. Audience input, expertise, and perspective will be encouraged throughout.

Why should you attend this workshop: This workshop will help enhance general preparedness to launch or defend against biosimilars and provide an opportunity, more specifically, to apply innovative approaches to more precisely predict the future and gain insights to inform your strategies and execution.

Agenda: 08.30 Registration & Coffee

09.00 Workshop leader introduction

09.10 Session 1: Stakeholders that will Influence Adoption • Overview of primary and secondary stakeholders • Discussion of role in biosimilar adoption by

stakeholder and potential evolution of influence as the landscape emerges

• Implications to approach to forecasting and market research based on key stakeholder implications

09.55 Session 2: Innovative Approaches in Market Research with Biosimilars

• Overview of “traditional” approaches taken in MR and forecasting

• What’s different for biosimilars • Interactive activity/ discussion to share

innovations or new considerations attendees have been utilizing

10.40 Morning Coffee

11.10 Session 3: Innovative Approaches in Forecasting with Biosimilars

• Overview of “traditional” approaches taken to forecasting with specialty biologics

• What’s different for biosimilars, including any unique thoughts related to variability by TA/ situation (as applicable)

• Interactive activity/ discussion to share innovations or new considerations attendees have been utilizing

11.55 Session 4: Envisioning the Future • ZS POV on potential variability in uptake

scenarios (and drivers by stakeholder, influencer of those scenarios)

• Interactive discussion: working table groups to divide and discuss how those variable uptake scenarios may impact approach to gathering insights via MR activities

12.30 Final Discussion and Close of Workshop

About the Workshop Leaders:Tucker Herbert is a Manager with ZS in the Los Angeles office. Tucker has advised major biotechnology firms on a broad range of sales and marketing strategy issues related to the biotech industry, with an emphasis on Oncology

and Biosimilars. His experience has focused on global quantitative and qualitative primary market research and forecasting. Tucker was one of the founding members of ZS’s Biosimilars Vertical, and he has led over 30 training sessions across North America and Asia on the topic. Tucker holds an M.B.A. with honors from UCLA, and a B.A. with honors from Stanford University.

Christina Corridon is an Associate Principal in the ZS Boston office. Christina is the ZS Space Leader for the Biosimilars Industry Vertical. Her experience in global pharma, includes launch, go-to market strategy, and customer engagement. Christina

leads the competitive scenario/ war game offering at ZS and has extensive experience in scenario planning/ war gaming in the biologics, biosimilar spaces. Christina has an MPH in Health Policy and Management from the UCLA Fielding School of Public Health and an MBA from the Stern School of Business at New York University focused in Marketing. Christina completed her BA at Cornell University.

About the Organisation:ZS Associates is a management consulting firm focused on the healthcare industry that leverages data-driven insights to advise our clients on critical aspects of their commercialization strategy. The ZS Biosimilar

Vertical is dedicated to helping clients understand the rapidly shifting and highly competitive biosimilar landscape by identifying and leveraging the opportunities where a manufacturer (originator or biosimilar) can have influence.

HALF-DAY PRE-CONFERENCE WORKSHOP ATuesday 13th November 2018

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 08.30 – 12.30

Dealing with Life Sciences Patents at the PTAB

Workshop Leaders: Ha Kung Wong, Partner, New York, Fitzpatrick, Cella, Harpper & Scinto

John Kirkland, Director, Intellectual Property, Alkermes, Inc.

Workshop Overview: We will discuss trends for life science patents (including both small molecule and biologics) at the PTAB with respect to Inter Partes Review and Post Grant Review including a review of pertinent case law, strategies for writing petitions and responding to petitions as well as tips for handling depositions and oral hearings.

Why should you attend this workshop: After the Supreme Court’s decision in Oil States confirmed the Constitutionality of IPRs and PGRs, we can only expect the increasing use of these challenges in the life sciences to continue. IP practitioners need to be prepared for how to prepare to protect their IP assets as well as how to challenge IP assets that may impact their future products.

Agenda:

13.30 Registration and Coffee

14.00 Workshop leader introduction

14.10 Session One Title: Primer on Inter Partes Review and Post Grant Review

• Overview of both IPR and PGR Process

14.30 The Impact of Oil States and SAS Supreme Court Decisions

• Discuss Oil States • Discuss SAS • Discus PTAB Guidance re Decisions

15.00 Afternoon Tea

15.20 Life Science Patent Trends at the PTAB • Review statistical trends for Life Science patents

at the PTAB including institution rates, invalidation rates and impact of claim types

15.40 Tips for IPR & PGR Trials • Key Issues for Drafting and Responding to

Petitions • Importance of Expert Declarations & Depositions • The Hearing

16.25 Workshop Exercise regarding PTAB Proceedings

17.30 Final Discussion and close of Workshop

About the Workshop Leader: Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics and chemistry. Cases Ha Kung has

litigated include those related to siRNA, proton pump inhibitors, anti-epileptic drugs, anti-tussives and other pharmaceuticals. Mr. Wong also has extensive experience with inter partes review (IPR), post grant review (PGR), intellectual property counseling, pre-suit investigations, licensing and due diligence.

Mr. Wong is the recipient of the 2017 ILO Client Choice Individual Award for Intellectual Property in New York. He is currently the Chair of the Recruiting Committee, serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a “Furthered 40” by Lawline for his contributions. He is also an Advisory Board Member for The Center for Biosimilars.

Ha Kung was named to The National Law Journal’s 2017 inaugural list of Elite Boutique Trailblazers.

John Kirkland is a Director of Intellectual Property at Alkermes, Inc., a global biopharmaceutical company focused on the development of innovative treatments for central nervous system (CNS) disorders. He is responsible for managing all aspects of the IP portfolio related to litigation. Before moving to Alkermes, he was Counsel at Fitzpatrick, Cella, Harper & Scinto, where he focused his legal practice on intellectual property strategy, patent litigation, including Hatch-Waxman litigation and post-grant proceedings. He received his B.A. in Biochemistry and Molecular Biology from Rutgers College and his J.D. from Cardozo Law.

HALF-DAY PRE-CONFERENCE WORKSHOP BTuesday 13th November 2018

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 13.30 – 17.30

BIOSIMILARS USA Conference: Wednesday 14th & Thursday 15th November 2018, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Workshops: Tuesday 13th November 2018, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

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