Chairperson

Key Speakers Include:

Benefits of attending:• Gain up to date insight into the regulatory landscape and how it is effecting the industry

• Evaluate commercialization and development strategies togain a competitive advantage

• Calculate possible revenue streams from biosimilar production• Discover what lessons have been learned so far and what the

future holds• Boost your industry knowledge and relationships by networking

and learning from key industry and academic leaders

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 9th April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

A: Differentiation Strategies for theGenerics Industry

Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0

8.30am - 12.30pm

B: Launching a Biosimilar in an Innovator v. Generic World

Workshop Leader: Kristie Kuhl, JD, Executive Vice President, Health Practice, Makovsky

1.30pm - 5.30pm

Dr Richard Dicicco, Chairman,

Harvest Moon Pharmaceuticals

• Dr John Pakulski, Senior Director, and Head USBiopharmaceutical Regulatory Affairs, Sandoz

• Rodeina Challand, Executive Director, Biosimilars Development,Scientific Affairs, PRA International

• Dr Stanley (SeungSuh) Hong, President, Research andDevelopment, Celltrion, Inc.

• Paul Ashton, President & CEO, pSivida• Peter Pitts, President, Center for Medicine in the Public Interest

(Former FDA Associate Commissioner)

• Douglas M. Long, Vice President, Industry Relations, IMS Health

• and many more!

“A thoroughly interesting and very informative conference withexcellent chairs and presenters. More of the same please.” Biosimilars & Biobetters Europe 2013 Attendee

SMi present their inaugural conference on… 7th - 8thAPRIL2014

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Creating an Innovate Plan for the USABiosimilars Market

Biosimilars & Biobetters USA

BOOK

BY

20TH DECEM

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ANDSAVE $300

BOOK

BY 28TH FEBRUARY

ANDSAVE $100

Sponsored by

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

ACADEMIC & GROUPS DISCOUNTS AVAILABLE

Register online at: www.biosimilars-usa.com • Alternatively fax yo

Biosimilars & Biobetters USADay One I Monday 7th April 2014 www.biosimil

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksDr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

REGULATORY AND MARKET REVIEW (PART 1)

OPENING ADDRESS9.10 Biosimilars and specialty products: current status and future

• Understanding how the global pharmaceutical market is becoming

more specialized and precise

• Identifying what the experience on follow on biologics, generics

and biosimilars has been so far

• Assessing what role follow on biologics, generic biologics and

biosimilars play in the future

Douglas M. Long, Vice President, Industry Relations, IMS Health

9.50 Ensuring that interchangeability does not thwart US innovation – legislation at both federal and state level and FDA’s expectations• Assessing the risk of interchangeability to biologic innovation

• Understanding the basis for interchangeability at state and federal

level

• Analyzing the variations in state-level legislation governing biosimilar

substitution

• Reaching a consensus on interchangeability - how and when should

this be permitted

• Determining whether physicians should be notified when

pharmacies substitute biosimilar for brands

• Preparing for future FDA guidance regarding safety and quality

considerations for interchangeable products

Dr John Pakulski, Senior Director and Head US BiopharmaceuticalRegulatory Affairs, Sandoz

10.30 Morning Coffee

10.50 Biosimilars - the state of the union • Reviewing current regulatory concerns

• An update on biobetters and biosimilars

• Discussing the EU experience

• Analysing cost versus quality

Peter Pitts, President, Center for Medicine in the Public Interest (FormerFDA Associate Commissioner)

11.30 Ready, set, go! …… but watch out for IP hurdles along the way in an age of post-patent medicine! • Reviewing the impact of patent laws on biosimilar production

• Identifying and overcoming the potential patent pitfalls biosimilar

applicants may encounter pertaining to:

- development

- marketing

- approval

• Evaluating how to challenge patents and potential patent

extensions from innovator companies

Dominic Adair, Senior Associate, Patent Litigation, Bristows

12.10 Networking Lunch

COMMERCIALIZATION & PRODUCT DEVELOPMENT STRATEGIES(PART 1)

1.30 Considering the impact of biosimilars on competition

• Examining the balance between innovation and competition

• Analysing potential entry into the USA market

• Reviewing the European experience of biosimilar production

- barriers to entry

- market opportunities

- competitive response

- differences in the biosimilars versus biobetter route

Professor Joseph Fuhr, Professor of Economics, Widener University

2.10 Insights into the structure function relationship of monoclonal

antibodies (mAbs) with respect to their evaluation of biosimilarity

• Ensuring quality CMC is in place before embarking on mAb

production to achieve successful biosimilarity

• Considerations for building a pipeline of mab biosimilars

• Understanding why US mAbs will be an important target for the

development of biosimilar therapeutic products

Dr Magdalena Leszczyniecka, President and CEO, STC Biologics

2.50 Physician's perspective on biosimilars: the importance of

pharmacovigilance

• Understanding why patient safety is paramount

• Realizing that information is power: the more doctor's have, the

better it is for patients

• Examining why manufacturers must be transparent for physician's to

have confidence in the product

Dr Richard Dolinar, Chairman, Alliance for Safe Biologic Medicines

3.30 Afternoon Tea

PRICING & COST RETURNS

3.50 Evaluating the potential revenue streams achievable from biosimilar

production

• Biosimilar investing: what to expect for a return on investment (ROI)

• Presenting a biosimilar sales forecast from a manufacturing view

• Profit margins in biosimilar production

• Evaluating biosimilar unit floor prices in a hyper-competitive market

Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

4.30 What is the state of play! Highlighting what lessons have been learned

to date and where the industry is heading

• Discussing industry insights and what work you should be planning to do

• What opportunities are awaiting the market

• Deciding which models to use for successful biosimilar launch

• What benchmarks can be learned from biosimilar development in

Europe

Rodeina Challand, Executive Director, Biosimilars Development,

Scientific Affairs, PRA International

Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

5.10 Chairman's Closing Remarks and Close of Day One *Subject to final confirmation

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our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Biosimilars & Biobetters USADay Two I Tuesday 8th April 2014lars-usa.com

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksDr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

REGULATORY REVIEW - PART 2

OPENING ADDRESS9.10 What is in a name! Reviewing the ongoing debate in the biosimilars

naming process to ensure appropriate pharmacovigilance! • Presenting an update on the FDA’s naming preference - determiningtheir stand on distinctive International Nonproprietary Names (INNs) forbiosimilars

• Assesing the options for long-term biosimilar naming: - Common non-proprietary name- Shared root or prefix- Distinct non-proprietary name

• Recognizing the need for clear naming principles to avoid patientsreceiving the incorrect product and reduce confusion amonghealthcare providers

Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International

9.50 Exploring the European (EU) biosimilars landscape to determine what lessons and ‘take homes’ the US market can employ • Analyzing current regulatory requirements for biosimilar approval inEurope and the future path of this legislation

• Reviewing the variations between the EU and US law and regulations • Implementing strategies for harmonizing US and EU developments toavoid program duplications

Liz Fuller, Partner, Bird & Bird

10.30 Morning Coffee

10.50 Essential infrastructure for successful mAb biosimilar development • Introduction of biosimilars and how to secure the comparability toreference products

• Highlighting key global opportunities of mAb biosimilars • Understanding the key infrastructure for successful biosimilardevelopment

• Approval of world’s first mAb biosimilar from both developed andemerging countries

• Utilizing bridging studies to enable the application of alreadygenerated data

Dr Stanley (SeungSuh) Hong Ph.D. President, Research andDevelopment, Celltrion, Inc.

MARKET ACCESS FOR BIOBETTERS

11.30 Biosimilars vs. biobetters! Determining the implications for product developers in the pharmaceutical industry • Biobetters claim that they are a better product, but what evidence isthere to prove this?

• Discussing the regulatory status pertaining to production of biobetters • Analyzing which features can be improved by utilizing biobetters • Evaluating whether biobetters are better than biosimilars based onefficacy, safety and delivery

Paul Ashton, President and CEO, pSivida

12.10 Networking Lunch

1.30 Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars • Reviewing the challenges and opportunities in developing relatively cost effective biosimilars

• Innovations in improving the existing biologics therapies in diseases with unmet medical needs

• Making biobetters or biosuperiors successful and cost effectivethrough advances in protein engineering and pioneeringtechnologies - case studies of biosuperior vs. biosimilars

• Identifying which products have significant potential for ‘biosuperior’development

• Developing biosuperior protein therapeutics that address sub-optimal,in-market characteristics of currently licensed biologics

• Examining current active projects in research and development ofbiosimilar and novel biobetter/biosuperior therapeutic proteins

Dr Rakesh Dixit, Vice President, R & D Head, Global Biologics SafetyAssessment, MedImmune (AstraZeneca Biologics)

COMMERCIALIZATION AND PRODUCT DEVELOPMENTSTRATEGIES (PART 2)

2.10 Identifying how to create a truly marketable product! Assessing commercialization considerations for biosimilars• Understanding the role of partnerships in the development anddelivery of commercially successful biosimilars to secure specificcapabilities

• What are the various partnership models to consider in co-commercializing

• Providing relevant preclinical and clinical data for marketingauthorization

• Honing marketing tactics to achieve accelerated biosimilars sales • Ensuring sufficient manufacturing capability and human capital toproduce and commercialize biosimilars

Dr Branimir Cvetkovic, Global Strategy Lead – Biosimilars, Novartis

2.50 Designing effective strategies to achieve excellence in clinical trials • Identifying the key operational considerations for delivering highquality trials on time and budget : - What size should the trial be- How many patients should be exposed to the drug

• What trial design should be used • Developing strategies to optimize patient recruitment and retention inclinical trials

• Examining the benefits of investigator/ patient education • Implementing non clinical and clinical data to guaranteepharmacovigilance for biosimilars

Session reserved for Pfizer further to final speaker confirmation *

3.30 Afternoon Tea

3.50 Creating effective strategies to control the manufacturing process and address the unique challenges facing biosimilar producers • Overcome challenges in developing biosimilars through formulatedtesting strategies:

- analytical and bioanalytical method development capabilities - defined characterization programs

• Implementing procedures to prepare your manufacturing lifecycle foreach step of product development

• Applying the fundamentals of process analytical technology (PAT) • Discovering how a small difference in the manufacturing processmay create a different product

• Understanding the importance of supply-chain expertise procurementand quality assurance to speed up development

Dr Steve Flatman, Head Biosimilars Research and Development, LonzaBiologics plc

4.30 The optimal manufacturing strategy! - Exploring what is shaping the strategic biosimilar manufacturing plan of today's leading companies • Discovering how to build or procure this manufacturing base in a costeffective way

• Evaluating where should this manufacturing base be located and why• Analysing how competition from new players is changing thelandscape

Kristopher Howard, Managing Director, Operational Excellence Leader,NRL Enterprise Solutions

5.10 Chairman’s Closing Remarks and Close of Day Two

*Subject to final confirmation

Supported by

PANEL

DISCUSSION

Overview of workshop:This workshop will help to develop an expertunderstanding of the differentiation strategies used inworldwide markets, to explore new ideas andopportunities for differentiation, plus possiblerequirements demanded by industry evolution.

Why you should attend:Gain insights into the future of the generic industryand how differentiation might be the only option forsuccess.

Programme:

8.30 Registration & Coffee

9.00 Introductions and opening remarks

9.10 Session 1: Current differentiation tactics in global markets

9.50 Session 2: The challenges that differentiation brings

10.30 Coffee Break

11.00 Session 3: Ideas for differentiation

11.40 Session 4: The future of the industry and why differentiation is needed

12.20 Closing remarks

12.30 Workshop ends

About the workshop host:Asa has been involved in the generic pharma sectorfor over 16 years; covering all aspects of the industry,both commercial and technical. Asa launchedgenericlicensing.com in 2008. The platform nowmanages more than 9000 products and is used bygeneric companies the world over. Asa createdGeneric Pharma 2.0 in 2010 as a vehicle to convertsubstantial market intelligence into a dedicatedconsulting company. The firm now consults withclients on portfolio strategy, international marketentry and pharmagination models.

About Generic Pharma 2.0Generic Pharma 2.0 are ‘masters of businessdevelopment & marketing’. Established in 2008,Generic Pharma 2.0 has built a global network of30,000 companies; achieved by combining ferociousbusiness development and the latest webtechnologies. It offers clients both access to anetwork and the intelligence gained from a uniqueperspective. We work with companies of all sizes,locations and product categories. We partner withclients. We create together. We have a lot of fun.

Differentiation Strategies for theGenerics Industry

Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0

HALF DAY POST CONFERENCE WORKSHOP AWednesday 9th April 2014 I 8.30am – 12.30pm

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Want to know how you can get involved?Interested in promoting your services to this market?

Contact Julia Rotar, SMi Marketing on +44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and

branding packages, uniquely tailored to complementyour company’s marketing strategy. Prime

networking opportunities exist to entertain, enhanceand expand your client base within the context of an

independent discussion specific to yourindustry. Should you wish to join the increasing number

of companies benefiting from sponsoring ourconferences please call:

Alia Malick, Director on+44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

Overview of workshop:This interactive workshop will discuss the uniqueaspects of successfully launching a biosimilar in theUnited States. Topics to be discussed include:

• Filing a BLA or sBLA – when to determine the pathto approval

• Government affairs – likely allies and foes ofbiosimilars, what regulations to expect

• Marketing – what level of support will biosimilarsneed

• Revenue discussion – what will reimbursementlook like. How will the major biologics beimpacted and when

Why you should attend:Attendees of this interactive workshop will have theopportunity to learn the pluses and minuses ofvarious approaches about new products that fallbetween an innovator and a generic.

Programme:

1.30 Registration and coffee

2.00 Introductions and opening remarks

2.10 Session 1: BLA v sBLA

2.50 Session 2: USA regulation & substitution update – friends and foes

3.30 Coffee Break

4.00 Session 3: Marketing

4.40 Session 4: Revenue and reimbursement

5.20 Closing remarks

5.30 Workshop ends

About the workshop hosts:Kristie Kuhl, JD is Executive Vice President and DeputyPractice Head at Makovsky Integrated Communications.Her experience as a regulatory communications attorneyand counselor on biosimilar challenges started in 2005. Sheis a sought-after expert on biosimilars, and has served as apanelist and/or session leader at more than 10 biosimilarsconferences since 2006. She was instrumental in creatingand executing the Pfizer Genotropin communicationsstrategy when the company feared biosimilar entry inEurope would collapse the growth hormone market. Kristiehas been hailed for her knowledge of legalcommunications, media strategy and account-teammanagement. She bridges the divide between publicrelations and public affairs. Utilizing her legal and publicrelations background, Kristie is a counselor oncommunications strategy.

About MakovskyMakovsky is a leading healthcare communicationscompany in its ongoing mission to improve the lives ofpatients served by biotech, pharmaceutical and devicemanufacturing companies. Through giving voice topatients in advocacy programs, brand communicationsand disease education, Makovsky connects audiences viasocial media, news coverage and engagement at thoughtleader events such as TEDMED, Prix Galien and medicalcongresses such as ACOG, ASCO and AHA. The Makovskyteam lives with intent; fostering deep knowledge of theunderlying science, a profound understanding of theregulatory space, and a sensitivity to the complexinteractions between patients, physicians, researchers andregulatory agencies. In 2013 alone, Makovsky received 11healthcare communications industry awards, including“Best in Healthcare,” “Best Education/Public ServiceCampaign,” and “Best of the Best” across other industrysectors.

Launching a Biosimilar in anInnovator v. Generic World

Workshop Leader: Kristie Kuhl, JD, Executive Vice President,

Health Practice, Makovsky

HALF DAY POST CONFERENCE WORKSHOP BWednesday 9th April 2014 I 1.30pm – 5.30pm

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

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If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk

BIOSIMILARS & BIOBETTERS USAConference: Monday 7th April & Tuesday 8th April, 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA I Workshops: Wednesday 9th April 2014, New Jersey

4 WAYS TO REGISTERONLINE www.biosimilars-usa.com

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I would like to attend: (Please tick as appropriate) Fee Conference & 2 Workshops $2997.00 Conference & 1 Workshop $2398.00 Conference only $1799.00 2 Workshops only $1198.00 1 Workshop only $599.00Workshop A Workshop B

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VENUE Renaissance Woodbridge Hotel, 515 U.S. Route 1, Iselin, NJ 08830

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