DIA Biosimilars 2013November 13-14 | Bethesda, MD

CHALLENGES, INNOVATIONS, AND TECHNOLOGIES

OVERVIEW:With the expiration of numerous patents for originator biologicals over the next decade, the market for biosimilars continues to grow with rapid force. In fact, the global biosimilars market is expected to double by 2017. To help support this growing sector, this meeting will focus on the challenges, innovations, and technologies surrounding biosimilars.

This two-day meeting will provide an interactive format to discuss biosimilarity. Day one will focus on the US & EU Regulatory Landscape. Topics will include:

• Harmonization

• EU Guidance on Monoclonal Antibodies

• Bridging

• Immunogenicity

• Interchangeability

• Endpoints

• Extrapolation

• Quality & Nonclinical

• Models for Demonstrating Therapeutic Equivalence

• Level of Physical, Chemical, and Biological Similarity

Day two will focus on the Rest of the World, Commercialization and Emerging Markets. Topics will include:

• Commercialization, Naming, Labeling

• Automatic Substitution / State Laws

• Interchangeability

LEARNING OBJECTIVES:At the conclusion of this meeting, participants should be able to:

• Discuss the importance of a regulatory pathway for biosimilars that is distinct from the traditional generic approach

• Identify the unique challenges and complexities associated with demonstrating biosimilarity to a reference product

• Examine the implications for patients and doctors as biosimilars and (potentially) interchangeable biologics are introduced into the market

Register at diahome.org/Biosimilars2013DIA WORLDWIDE HEADQUARTERS800 Enterprise Road, Suite 200

Horsham, PA 19044, USA

WORLDWIDE OFFICESBasel, Switzerland I Beijing, China I Tokyo, Japan

Mumbai, India I Washington, DC, USA

PROGRAM COMMITTEE

Cecil J. Nick, MSFTOPRA, Vice President (Technical)PAREXEL Consulting, United Kingdom

Mary Ellen Cosenza, PhD, MS, RACExecutive DirectorUS Regulatory AffairsAmgen Inc.

David Gaugh, RPhSenior Vice President for Sciences and Regulatory AffairsGeneric Pharmaceutical Association (GPhA)

Richard M Lewis, PhDChief Executive OfficerAccess BIO

Sumant Ramachandra, MD, PhDSenior Vice PresidentR&D and Medical AffairsChief Scientific OfficerHospira, Inc.

Sundar Ramanan, PhDDirector Global Biosimilars PolicyRegulatory AffairsAmgen Inc.

Jian Wang, MD, PhDChief, Pre-market Clinical Evaluation Division - Haematology/OncologyHealth Canada, Canada

Joerg Windisch, PhDChief Science OfficerSandoz Biopharmaceuticals, Austria

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TO ACCESS PRESENTATIONS: • Visit diahome.org• Login to My DIA• Enter your User ID and Password• View ‘My Presentation Downloads’

Please Note: DIA User ID and Password are needed to access presentations. If you have forgotten your DIA User ID and Password, or this is your first time logging into the DIA website, please use our Login Reminder

DIA’S CERTIFICATE PROGRAM This program is part of DIA’s Certificate Program and is

awarded the following:

• Clinical Research Certificate Program: 8 Elective Units

• Regulatory Affairs Certificate Program: 8 Elective Units

For more information go to diahome.org/certificateprograms

CONTINUING EDUCATION CREDITS

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 13.75 contact hours or 1.375 continuing education units (CEU’s).

Type of Activity: Knowledge

ACPE Credit Request UpdateDIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit http://www.nabp.net/.

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; (703) 506-3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.4 CEUs for the program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

If you would like to receive a statement of credit, you must attend the program, sign-in at the DIA registration desk each day of the program, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, November 27, 2013.

It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda, and CE information are subject to change without notice. Recording of any DIA educational material in any type of media, is prohibited without prior written consent from DIA.

PHARMACY CREDIT ALLOCATION• Day 1: Welcome, Keynote, Sessions 1, 2 & 3, Part I: 4.75 contact hours or .475 CEUs; 0286-0000-13-081-L04-P• Day 1: Sessions 3, Part II & 4: 3 contact hours or .3 CEUs; 0286-0000-13-082-L04-P• Day 2: Sessions 5 & 6: 3 contact hours or .3 CEUs; 0286-0000-13-083-L04-P• Day 2: Sessions 7, 8 & Closing Remarks: 3 contact hours or .3 CEUs; 0286-0000-13-084-L04-P

View DIA’s grievance policy at diahome.org/CE

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DAY 1 | WEDNESDAY, NOVEMBER 13

7:15-8:00 am REGISTRATION AND CONTINENTAL BREAKFAST

7:55-8:00 am WELCOME AND OPENING REMARKS

Cecil Nick BSc (Hons.) FTOPRAVice President (Technical)PAREXEL Consulting

8:00-8:45 am KEYNOTE SESSION

Key Challenges Companies are Facing in the Development of Biosimilars Leah A. Christl, PhD Associate Director for Therapeutic Biologics, OMBT, OND CDER, FDA

8:45-10:45 am SESSION 1

Quality Considerations for Biosimilarity SeSSion Chair

Sundar Ramanan, PhDDirectorGlobal Biosimilars PolicyRegulatory AffairsAmgen, Inc.

Quality (chemistry, manufacturing and controls) plays a larger role in biosimilar development than traditional biologic medicine development. The challenges as well as opportunities are many. This session will cover diverse topics including analytical (physiochemical and functional) considerations, drug product development utilizing QbD and post-approval considerations. In addition, keeping with long-standing successful DIA tradition of bringing diverse perspectives these topics will be presented by various biosimilar developers. Attendees will be able to gain insights into various biosimilar development strategies, interact with peers from regulatory agencies and industry in sessions enabling cross-functional discussions.

Post Approval Regulatory Considerations for BiosimilarsGino GramppBiosimilars R&D Policy DirectorAmgen

Level of Physicochemical and Biological SimilarityEmily ShacterIndependent Consultant ThinkFDA, LLC

Role of Functional Assays in the Assessment of SimilarityCornelius Fritsch, PhDPrincipal ScientistAnalytical R&D Novartis

Drug Product Development of Biosimilars: Quality by Design Considerations and StrategiesKrishnan Sampath Associate DirectorGlobal Biologics Process DevelopmentHospira Inc.

Practical Considerations for Biosimilarity DevelopmentJim Anderson, PhDVice PresidentAnalytical Development Momenta Pharmaceuticals

Panel Discussion

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10:45-11:15 am SESSION 2

Demonstration of Biosimilarity: Nonclinical Considerations and ChallengesSeSSion Chair

Mary Ellen CosenzaExecutive DirectorUS Regulatory AffairsAmgen Inc.

The nonclinical studies consist of pharmacology, pharmacokinetics and/or toxicology studies, and while the nonclinical studies are an important component of the biosimilarity exercise, the regulatory authorities generally recommend an abbreviated approach (vs. the traditional nonclinical package) be applied in demonstrating a proposed biosimilar is similar to the reference product. Certain challenges must be addressed when conducting comparative nonclinical studies, including selection of relevant in vitro and/or in vivo models and the development of the analytical assays. This presentation will review the various points that should be considered in designing a nonclinical package as part of the biosimilarity exercise, as well as provide an overview of the challenges that often arise when performing these nonclinical studies.

Barbara Mounho-ZamoraBiopharmaceuticals/Pharmaceuticals Practice LeaderToxStrategies

11:15-11:30 am REFRESHMENT BREAK

11:30 am-1:00 pm SESSION 3, PART I

Clinical SeSSion Co-ChairS

Cecil Nick BSc (Hons.) FTOPRAVice President (Technical)PAREXEL Consulting

Jian Wang, MD, PhDChief, Pre-market Clinical Evaluation Division - Haematology/Oncology,Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics,Biologics and Genetic Therapies Directorate, Health Canada

This session will cover the challenging clinical safety, efficacy, and practice issues faced by manufacturers, regulators and healthcare professionals in developing, authorizing and prescribing biosimilars.

PKPDJohn R Lambert Vice PresidentPAREXEL Early Phase

Demonstrating Equivalent EfficacyKerry BarkerSenior Director Leadership, Bio-Therapeutics ResearchPfizer Inc

Clinical Data ExtrapolationCarlos Sattler, MDVice PresidentUS Clinical Development and Medical AffairsSandoz

1:00-2:00 pm LUNCHEON

2:00-3:30 pm SESSION 3, PART II

Clinical

ImmunogenicityMeena Subramanyam, PhD Vice PresidentDevelopment Translational MedicineBiogen Idec

Interchangeability Jaap Venema, PhD, PMPTherapeutic Area Lead BiotherapeuticsGlobal Medical AffairsAbbVie

Jim Roach, MDSenior Vice President & Chief Medical OfficerMomenta Pharmaceuticals, Inc.

Panel Discussion

3:30-4:00 pm REFRESHMENT BREAK

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4:00-5:30 pm SESSION 4

Lessons from the EU SeSSion Chair

Joerg Windisch, PhDChief Science Officer Sandoz BiopharmaceuticalsChair of the European Biopharmaceuticals Group (EBG) of the European Generic Medicines Association (EGA)

The European Union (EU) was the first jurisdiction to introduce legislation for biosimilars in 2004, followed by the issuance of guidelines by European Medicines Agency (EMA). Today, the EU has multiple biosimilars on the market, some of which go back more than seven years. Also, the EU has developed a detailed framework of guidelines for biosimilars, many of which are currently being revised based on the experience gained. This session will review the evolution of the regulations for biosimilars in the EU and take a look into the future of these regulations. One of the key challenges going forward will be the harmonization of regulations in the US and the EU, so programs do not have to be duplicated. Regulators will share on the progress in the FDA-EMA cluster on biosimilars they have set up. Also, a report on a study conducted by the European Commission (EC) on the biosimilars markets in the various EU countries will be shared. This study analyzed which barriers need to be removed and which incentives need to be put in place to create a fair marketplace for biologics.

Regulatory Evolution in EUMartina Weise, MDVice ChairBiosimilar Medicinal Products Working PartyEuropean Medicines Agency (EMA)

Market Experience in EU

Steffen Thirstrup, MD, PhDProfessor Steffen ThirstrupMedical Advisor & Advisory Board MemberNDA Regulatory ServicesLicensing Division

Global Development: FDA-EMA Biosimilars Cluster Leah A. Christl, PhD Associate Director for Therapeutic Biologics, OMBT, OND CDER, FDA

Panel Discussion

5:30-6:30 pm NETWORKING RECEPTION

DAY 2 | THURSDAY, NOVEMBER 14

7:30-8:30 am REGISTRATION AND CONTINENTAL BREAKFAST

8:30-10:00 am SESSION 5

Commercialization SeSSion Chair

David R. Gaugh, RPhSenior Vice President for Sciences and Regulatory AffairsGeneric Pharmaceutical Association (GPhA)

During this session, government and industry experts, from a broad range of backgrounds and experiences, will provide in-depth overviews on substitution and interchangeability and on naming and labeling as they relate to the biosimilar market. Experiences from the European biosimilar market as well as other non-US regulated markets will be incorporated to provide overviews.

Interchangeability & Substitution Gillian Woollett Vice President Avalere

Steve Miller, MDSenior Vice President & Chief Medical OfficerExpress Scripts

Thomas Felix R&D Policy DirectorGlobal Regulatory Affairs and SafetyAmgen

Naming & Labeling Erika Lietzan, JDPartnerCovington and Burling LLP

Joerg Windisch, PhDChief Science Officer Sandoz BiopharmaceuticalsChair of the European Biopharmaceuticals Group (EBG) of the European Generic medicines Association (EGA)

Panel Discussion

10:00-10:30 am REFRESHMENT BREAK

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10:30 am-12:00 pm SESSION 6

Postmarketing & Risk Management SeSSion Chair

Sumant Ramachandra, MD, PhDSenior Vice President, Research & Development and Medical Affairs Chief Scientific OfficerHospira Inc.

In this session, industry experts in pharmacovigilance will provide perspectives on post-approval safety evaluations and risk management plans/REMS for biologics and biosimilars. Using case studies, global experience with such programs will be reviewed with a focus to understanding challenges and opportunities.

Postmarketing Requirements and Pharmacovigilance Freddy J. Faccin, MDAssociate Medical Director, Latin AmericaBiotherapeutics, Immunology Medical AffairsAbbVie

Trending, Signal Detection and RiskJuergen Schmider, MD, PhDVice President Global Pharmacovigilance and Product Safety Hospira

Panel DiscussionMartina Weise, MDVice ChairBiosimilar Medicinal Products Working PartyEuropean Medicines Agency (EMA)

12:00-1:00 pm LUNCHEON

1:00-2:30 pm SESSION 7

Global ConsiderationsSeSSion Chair

Mary Ellen CosenzaExecutive DirectorUS Regulatory AffairsAmgen Inc.

Jian Wang, MD, PhDChief, Pre-market Clinical Evaluation Division - Haematology/Oncology,Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics,Biologics and Genetic Therapies Directorate, Health Canada

This session will provide high-level reviews on the regulatory framework developed for biosimilars in Canada and in key Latin America and Asia Pacific markets, identifying similarities and differences in the regulatory requirements in these markets.

Canadian PerspectiveAnthony Ridgway Senior Regulatory ScientistOffice of the Director at Health Canada OttawaCanada Area Government Administration

Mexican PerspectiveChristian Alejandro Lopez-SilvaBiotech & Nanotech Law Partner Tsuru, Morales & Tsuru, Mexico

Asian PerspectiveHeeKyung KimVice PresidentRegulatory Affairs Samsung Bioepis Co., Ltd, Korea

Panel Discussion

2:30-3:00 pm REFRESHMENT BREAK

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Celebrate the Past — Invent the Future

Where Life Sciences Professionals Converge to Advance Therapeutic Innovation, Foster Collaboration, and Accelerate Safer Products

Visit diahome.org/DIA2014 for more details.

Registration

Now Open!

Program Co-chairs:Sandra L. Kweder, MD, FACPDeputy Director Office of New Drugs CDER, FDA

Freda C. Lewis-Hall, MD, FAPAChief Medical Officer and Executive Vice PresidentPfizer Inc

DIA 2014 50th Annual MeetingJune 15-19, 2014 | San Diego, CA

3:00-4:00 pm SESSION 8

Monoclonal Antibodies SeSSion Chair

Richard Lewis, PhDChief Executive OfficerAccess BIO

Monoclonal antibodies will be an important target for the development of biosimilar therapeutic products. This session will offer an example of the development of a monoclonal for the European market and some insights into the structure function relationship of monoclonal antibodies with respect to their evaluation of biosimilarity. The session will include a panel discussion of these issues and include the presenters and FDA.

Case StudyStanley HongPresident of Research and Development Celltrion Inc.

Technical Importance of Understanding Structural Activity RelationshipCecil Nick BSc (Hons.) FTOPRAVice President (Technical)PAREXEL Consulting

Panel DiscussionLeah A. Christl, PhD Associate Director for Therapeutic Biologics, OMBT, OND CDER, FDA

4:00-4:30 pm CLOSING REMARKS

Joerg Windisch, PhDChief Science Officer Sandoz BiopharmaceuticalsChair of the European Biopharmaceuticals Group (EBG) of the European Generic Medicines Association (EGA)

4:30 pm MEETING ADJOURNED