Providing Timely and Relevant Insight on Political, Safety, Regulatory and Strategic Implications of Pending Legislation

S e p t e m b e r 1 4 - 1 5 , 2 0 0 9 • G a y l o r d N a t i o n a l • N a t i o n a l H a r b o r , M D

Biosimilars and Follow-On Biologics

Biosimilars and Follow-On Biologics

Organized By: Outstanding Support

Provided by:

C B I ’ s 3 r d S u m m i t o n

Conference Co-Chairs:

Juliana Reed, Vice President Government Affairs, Hospira, Inc.

Gil Bashe, Executive Vice President, Makovsky + Company

Additional Faculty from:

BIOGlaxoSmithKlineGlenmark GenericsHogan & Hartson LLPHospira, Inc.HPS Group LLCMedImmuneNORDNPS PharmaceuticalsPfizer IncSandozsanofi-aventisVinson & Elkins LLPWyeth

Legislative and Regulatory Addresses

The Pathway for the Biosimilars Act Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.

Promoting Innovation and Access to Life-Saving Medicines ActAnn M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives

Analyze Patient Safety Concerns and Biologic/Biosimilar ComparabilityEmily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins,

Office of Biotechnology Products, CDER, U.S. Food and Drug Administration

Assess Antitrust Concerns and the Competitive Impact of Biosimilars Suzanne Drennon, Counsel for Intellectual Property, Bureau of Competition,

Federal Trade Commission

Featured Sessions

Healthcare Policy and Payment Perspective — Reimbursement Payment System and Benefit Design Implications

James Langley, Vice President Reimbursement, Accredo Health Group

Analyze the Commercial and Economic Implications of Biosimilars Legislation

Biotech Market Analysis – Mark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank

Biosimilars Market Analysis – R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP

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CLE Credits Available

Pending Approval

Dear Colleague, For the last three years it has been said that this is the year that an approval pathway for biosimilars will be created. With two competing bills in the House and one before the Senate, combined with the Obama administration allocating budget funding, this year that prediction might actually be right. What great news this is for the slowing pharma industry as biologics continue to outperform the global pharma market with premium prices and specialty therapies that cannot be treated with conventional drugs. Biosimilar market entry carries high hopes for those willing to take the risk, and it is becoming clear that many are. For several years now, the bio/pharmaceutical industries have been debating the policy of this pathway, along with many other political and government organizations. For much of this time, the data on which these arguments were founded was dubious at best, but since the U.S. has found itself trailing other countries in creating this pathway, more data is becoming available in terms of costs, pricing and market effects. So although the actual market effects of an approval pathway for biosimilars in the U.S. will never truly be known until they’ve happened, as an industry, we have enough collective information now on which to base our individual company decisions and start taking our next steps – no matter if a company’s steps are to enter the biosimilars market or to protect their innovative biologic from a lower priced alternative. Because the fact is, an approval pathway is going to be created. And whether it occurs sooner or later, don’t you think you should be ready? All of these considerations were in play in developing CBI’s 3rd Summit on Biosimilars and Follow-On Biologics, taking place September 14-15, 2009 at the Gaylord National, National Harbor, MD. Through our esteemed and diverse faculty, this meeting gathers the collective information from many facets of industry to share with the delegates over two days of keynote presentations, panel discussions and case studies. Key policy makers, regulators, analysts, healthcare organizations and bio/pharma companies are on hand to share their timely, relevant and practical insights so that delegates can best advise their companies on next steps – and more importantly, start taking them. As conference Co-Chairperson, I invite you to join us in September for this critical juncture in the evolution of healthcare and the bio/pharma industry. I will be sharing the stage with an impressive group of representatives from the Office of Henry Waxman, FDA, FTC, BIO, MedImmune, Pfizer, Sandoz, GSK, NORD, Deloitte, Deutsche Bank, Genzyme, Genentech, Accredo Health and many more. I look forward to meeting you this September! Sincerely,

Juliana Reed Juliana Reed Vice President, Government Affairs Hospira, Inc. P.S. Don’t miss Accredo Health’s presentation on understanding the reimbursement and benefit implications for biosimilars – it provides perspective from PBMs, CMS and Commercial Insurers!

MaIN CONFereNCe

Day One — Monday, September 14, 20098:00 Main Conference Registration and

Continental Breakfast

9:00 Co-Chairs’ Opening Remarks Juliana Reed, Vice President Government Affairs, Hospira, Inc.

Ms. Reed has overall responsibility for the Government Relations function which includes the oversight of global government relations and public policy initiatives for the corporation. As the first U.S. based company to launch a biosimilar product in Europe, Retacrit® (epoetin zeta), Hospira — the world leader in generic injectables — has the scientific expertise and manufacturing capabilities to bring biogenerics to market in the United States. Ms. Reed has also held positions in health policy and reimbursement, both at Hospira and Baxter Healthcare. In addition, Ms. Reed has extensive experience in U.S. healthcare, where she has worked as a hospital administrator and clinician. Ms. Reed holds a BS degree from Marquette University and a Master’s Degree from DePaul University. She is a licensed Physical Therapist and Nursing Home Administrator in the State of Illinois.

Gil Bashe, Executive Vice President, Makovsky + Company As executive vice president at Makovsky + Co., Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device manufacturers and patient-advocacy groups. He has advised clients on follow-on-biologic (FOB) policies and reimbursement, first in Europe and now in the United States. Through the years, Mr. Bashe has left his mark on health-product access. At the onset of the CMS Part D program, he helped change a Medicare drug benefit – ensuring continued reimbursement for a leading heart-disease medication. Mr. Bashe was CEO of CommonHealth, a WPP Group company, having served as vice-chairman for strategic planning. At sister-company Hill and Knowlton, he was worldwide Health Practice director overseeing policy, provider and product communications. In the frontlines of ensuring patients retain access to care; Mr. Bashe served as paratrooper commander and combat medic. He is an American Heart Association (AHA) New York past chair, and AHA regional affiliate board member. Mr. Bashe is co-editor of Branding Health Services: Defining Yourself in the Marketplace and a member of the American Pharmacists Association, National Lipid Association and the Society for Nuclear Medicine.

Policy Update and analysis

9:15 PathwayfortheBiosimilarsActOn March 17, 2009, Representatives Anna G. Eshoo, Inslee and Barton introduced a bill that would create an abbreviated pathway for the FDA to approve biosimilars. Eshoo’s bill differs significantly than the Waxman bill on several issues such as naming, clinical trials and exclusivity. This address discusses Eshoo’s proposed legislation and the intended outcomes of its provisions.• Compare the 2009 bill to the 2008 version• Discuss key provisions of the bill, what they are and

what they mean for industryKay Holcombe, Senior Health Policy Advisor, Genzyme Corporation Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.

10:00 PromotingInnovationandAccesstoLife-SavingMedicinesActOn March 11, 2009, House Energy and Commerce Chairman Henry Waxman and Representatives Pallone, Deal and Emerson introduced their version of bill that would give the FDA the authority to approve generic versions of biotech drugs. This address discusses this bill and how it differs from Waxman’s bill that was introduced to the 2007 Congress, as well as key points that set it apart from other pending legislation.

• Understand how and why this bill differs from the 2007 Waxman bill (H.R. 1038)

• Discuss key components to the legislation and their intended outcomes

Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives

10:45 Networking and Refreshment Break Hosted by:

11:15 ExplorethePoliticalPrinciples,ExpectationsandImplicationsofPendingBiosimilarsLegislationThe 2009 versions of biosimilars legislation are currently being debated among many parties with vested interests. While almost everyone can agree that it is time for a regulatory pathway to approve biosimilars or biogenerics, there is not yet a consensus of how to achieve this. This, coupled with the enormity of potential implications resulting from this pathway, has industry keeping a close eye on biosimilars policy. This panel discusses the pending legislation, the principles in which they are based, the force behind enactment on the Hill and expectations for implementation. The potential implications of pending legislation are also explored. • What is the public positioning of pending legislation?• What timelines for enactment and implementation

are most likely?• What are the potential implications for industry?

* patient safety* FDA’s resources* healthcare* ability to manufacture biotech drugs* ability to manufacture biosimilars

Moderator: Steven Grossman, President, HPS Group LLC Panelists: Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. Elizabeth Seifert, Director Public Policy, GlaxoSmithKline Kent Jancarik, Director Federal Policy, Pfizer Inc Diane Edquist Dorman, Vice President, Public Policy, National Organization for Rare Disorders (NORD)

12:15 Luncheon

evaluate the regulatory Challenges and expectations for Biosimilars

1:30 AnalyzePatientSafetyConcernsandBiologic/BiosimilarComparabilityThe foundation of the biosimilars debate is focused on patient safety — whether biosimilars can achieve acceptable levels of safety, including immunogenicity, and what level of clinical data is needed to ensure an acceptable risk. This address evaluates the factors of biologic comparability and provides an assessment of available data in relation to patient safety.• Explore the criteria used to evaluate comparability

of biologics

LeGISL atIv e aDDr eSSeS

FDa address

P O L I C Y P a N e L

• Assess available data supporting and opposing predictions on safety and immunogenicity

Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, U.S. Food and Drug AdministrationDr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins University in 1982, carried out basic research on cell regulation and cancer at the National Institutes of Health for twelve years, and then joined the FDA in 1994. Dr. Shacter oversees the review of INDs and BLAs for novel therapeutic proteins covering a wide range of clinical indications, including cancer, hematopoiesis, tissue repair, hemostasis, inflammatory diseases and bioterrorism. Dr. Shacter is engaged in establishing CDER policy regarding product manufacture and characterization and performs inspections of biotechnology manufacturing facilities. Dr. Shacter speaks frequently at national and international meetings on a wide range of topics related to the development and licensure of therapeutic proteins. She is an Agency expert on scientific issues associated with evaluation of follow-on biologics. Dr. Shacter also runs an active laboratory research program to support the scientific review of therapeutic proteins. Her laboratory research focuses on studying the cytotoxic mechanisms of cancer chemotherapy drugs and understanding how elements of the immune system, such as oxidants and activated phagocytes, influence killing and clearance of dying cells. Her research expertise in the area of protein oxidation is applied regularly to the review of protein therapeutics.

2:15 RegulatoryMechanisms,ConsiderationsandImplicationsofBiosimilarPolicyThe proposed regulatory pathways for the approval of biosimilars greatly vary on the mechanisms by which approval takes place. The mechanisms, in addition to being heavily debated, also bring up many questions and concerns about our regulatory system in general, like whether or not we are equipped to handle this change in our current state and what is the potential fall out of legislation. This panel discusses these issues in-depth from multiple perspectives. • What should the clinical data requirements be

for immunogenicity?• What should the clinical data requirements be

for interchangeability?• How descriptive or flexible will the legislation be?• How much authority will the FDA have to

make decisions?• How would the regulatory mechanisms for a

pathway be established? * universal model or class systems?

• What should the naming requirements be for biosimilars?

• What are the potential regulatory implications for biologics currently on the market?

Moderator: Steven Grossman, President, HPS Group LLCPanelists: Ross Lobell, Senior Director — Regulatory Affairs, MedImmune Brian E. Harvey, M.D., Ph.D., Vice President, Regulatory Policy, sanofi-aventis Philip Katz, Partner, Hogan & Hartson LLP

3:30 Networking and Refreshment Break

review antitrust Provisions and Lessons Learned from

Hatch-Waxman

4:00 AssessAntitrustConcernsandtheCompetitiveImpactofBiosimilarsThe unintended competition and antitrust issues that stemmed from Hatch-Waxman are a source of concern among industry and government when considering the structure of an abbreviated approval pathway for biosimilars. The desire to avoid pharma Hatch-Waxman-like issues in the biotech market prompted the FTC to take a proactive role in evaluating and shaping this impact by encouraging stakeholders to consider unintended consequences before hand. This address discusses these potential unintended anticompetitive consequences and how they are addresses in pending legislation, as well as the antitrust provisions and what they could mean for industry.

• Methods of patent disputes and resolution• Settlements and reverse payments• Authorized generics• Exclusivity• Forfeiture and other “parking” mechanismsSuzanne Drennon, Counsel for Intellectual Property, Bureau of Competition, Federal Trade Commission Ms. Drennon focuses on antitrust and intellectual property policy and enforcement. Prior to joining the FTC, Ms. Drennon was an antitrust and intellectual property litigator in Los Angeles. She received her A.B. in mathematics from Bryn Mawr College and her J.D. from the University of Minnesota Law School where she was Managing Editor of the Minnesota Law Review.

4:45 Close of Day One

Day Two — Tuesday, September 15, 2009

7:30 Continental Breakfast

8:00 Co-Chairs’ Review of Day OneJuliana Reed, Vice President Government Affairs, Hospira, Inc.

Gil Bashe, Executive Vice President, Makovsky + Company

4:45-5:45 Networking, Wine & Cheese Reception

Join colleagues and friends in a relaxed setting.

photo by: Photolink / Getty Images

r e G U L a t O r Y P a N e L

FtC address

“the conference gave me a good view of what important issues should be investigated for impact on my company.”

— Previous Attendee, Eric A. Utt, Ph.D., Specialty Market Access, Pfizer Inc

Identify the Commercial, economic and Strategic Implications of Biosimilars

AnalyzetheBiotechandBiosimilarsMarketsThe commercial and economic implications of biosimilars legislation are largely debated by industry, but remain fundamental to the business decisions of both biotech and biosimilar manufacturers and their key stakeholders. The following sessions provide an in-depth analysis of biotech and biosimilars markets with top economic, commercial, risk and strategic considerations.

8:15 BiotechMarketAnalysis• Understand the top biotech therapeutic areas and

patient population demographics• Evaluate the EU system and experience to date• Analyze biotech pricing performance and

market share• Assess the commercial impact of biosimilars legislation• Forecast the long term effects of an abbreviated

pathway on the risk-sensitive biotech industryMark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank

9:00 BiosimilarsMarketAnalysis• Review key factors affecting biosimilar market

creation and entry• Examine lessons learned from the EU • Discuss key considerations that will impact

biosimilar adoption• Identify the commercial opportunities for biosimilarsR.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP

9:45 BiosimilarsversusBiobetters—ASide-By-SideStrategicAnalysisSince the actual cost savings for biosimilars is still unknown, some of industry has been looking at a different “follow-on” biologic opportunity in biobetters. Biobetters are considered biologics that are similar to the original product but better in some way i.e. less side effects, reduced dosing schedule, better delivery system, higher absorption rate, multiple indications, etc. Biobetters may be considered traditional “Fast Follower” therapeutics where the strategy is to launch into established categories with a “best-in-class” brand profile. The evolving regulatory landscape will determine if Biobetters will face greater scrutiny or benefit from a streamlined development program. This session compares the opportunities and challenges to consider when deciding biosimilars or biobetters.• Traditional Biobetters — Recent case studies• Capture market share through price or

therapeutic benefits?• Are improvements in delivery sufficient to

accelerate adoption ?• Is a novel indication a requirement for regulatory

and commercial success?Robert Ward, Vice President, Corporate Development, NPS Pharmaceuticals

10:30 Networking and Refreshment Break Hosted by:

Understand the reimbursement and Benefit Implications for Biosimilars

11:00 HealthcarePolicyandPaymentPerspective—ReimbursementPaymentSystemandBenefitDesignImplicationsThis session evaluates likely government and commercial insurer payment/reimbursement policy strategies for biosimilars. The discussion focuses on three key areas including, 1) The PBM perspective — How will PBM’s view biosimilars and what drug utilization management models might they consider? What are the major concerns/issues impacting these models? 2) The Government Payor Policy — Key issues around CMS payment policy, both based on current systems/tools and potential emerging legislative implications; and 3) Commercial Insurers — Potential strategies to be utilized by commercial insurers including benefit category and payment systems considerations.• Review/discuss the major Reimbursement System

categories impacting biosimilar adoption • Evaluate the conflicting perspectives driving the

different major reimbursing entities — PBM’s, Government Payors and Commercial Insurers and discuss current and likely tools they may use

• Linking likely Payment System strategies with key clinical/patient safety considerations

James Langley, Vice President, Reimbursement, Accredo Health Group

examine Patent Dispute Mechanisms, IP Issues and Litigation Concerns

11:45 AnalyzetheMethodsofPatentDisputeandResolutioninPendingLegislationThe methods of patent dispute and resolution in pending biosimilars legislation differ substantially from those set forth in Hatch-Waxman and are a key component of the biosimilars debate. This session analyzes the methods outlined in pending legislation to provide a better understanding of what the mechanisms are and how they impact patent dispute strategies, while incorporating lessons learned from Hatch-Waxman and what they tell us for biologic patent disputes. • Methods for filing disputes• Timelines for notification and response —

Potential areas to delay or speed up litigation• Which comes first — Approval or litigation?• Are there penalties involved?• Will settlements and authorized generics be allowed

or encouraged?Sean Ryder, Director of Intellectual Property, Glenmark GenericsDavid Fox, Partner, Hogan & Hartson LLP

12:30 Luncheon

Case analyses

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1:45 CurrentandFutureIPChallengesforBiogenericsPlayers—AGlobalPerspectiveAs the U.S. finds itself trailing other countries in creating a pathway to approve biogenerics, a global (and strategic) approach to patent issues is warranted. In this session, we knock down the domestic “silo” approach to biogenerics patent issues as we consider the following issues from a global perspective:• The differences between pharma and biopharma

patent landscapes • Strategic implications of the patent landscape differences • Current and future patent challenges for global

biogenerics players • “Patently obvious” lessons learned from biogeneric

launches to dateNaomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Hospira, Inc.

2:30 AChangeinthePatentLitigationDynamic—Will“BigPharma”Become“BigGeneric?”Traditionally (with some exceptions), patent litigation under Hatch-Waxman has been thought of as a dispute between a “big pharma” and “small generic” company, but early observations of the biosimilars market is painting a much different picture. A number of big pharma companies have already shown interest in entering the follow-on market and more are popping up all the time. So what does “big generic” pharma mean to “small biotech” companies in the court room? How will this change in dynamic affect the biologics industry? The pharma industry? Only time will tell, but this panel of experts attempts to shed light on the future of patent litigation.• Analyze the Hatch-Waxman IP and patent landscape• Evaluate how the size of a company and litigation

resources impacts litigation• Understand the role of risk assessment in patent

disputes and how this may differ from a change in the dynamic

• Consider how biosimilars legislation could change the patent litigation dynamic across industry

Moderator: Constance S. Huttner, Partner, Vinson & Elkins LLP Panelists: Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Hospira, Inc. Hans Sauer, Ph.D., Associate General Counsel, BIO Mark Bowditch, Patent Attorney, Sandoz Geoffrey Levitt, Vice President, Chief Regulatory Counsel, Wyeth

3:30 Close of Conference

33% 22%

22%

11%12%

Attorney/Counsel Regulatory

Policy

Patents

Government Affairs

Previous attendee representation

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Providing Timely and Relevant Insight on Political, Safety, Regulatory and Strategic Implications of Pending Legislation

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Biosimilars and Follow-On Biologics

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— Top Reasons to Attend —

• Key policy updates from the Office of Henry Waxman, U.S. House of Representatives, Genzyme, NORD, Genentech, GlaxoSmithKline and Pfizer

• Biotech and biosimilar market analyses by Deutsche Bank and Deloitte LLP

• Healthcare policy and payment perspective by Accredo Health Group

• Patient safety concerns addressed by the U.S. Food and Drug Administration

• Antitrust and competition insights by the Federal Trade Commission

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