[SAMPLE] Specialty Physicians Discuss Their Opinions of the U.S. Biosimilars Market

Specialty Physicians Discuss Their Opinions of the United States Biosimilars Market Insights into thePotential Reactions of Key Customers and Influence on Market UptakeNA7B-52December 2011

ContentsSection Slide Numbers Executive Summary 3 Introduction 5 Physician Prescribing Behavior 14 Customer Purchasing Behavior 29 Regulatory Environment 44 Biosimilar Manufacturers 55 About Frost & Sullivan 70 NA7B-52 2

Executive Summary• The arrival of biosimilars, or highly similar copies of biopharmaceutical products, to the U.S. market is imminent. Although they have been available elsewhere—including Europe—for several years, physicians and other key stakeholders in the United States have only recently begun to anticipate their arrival.• This panel discussion was conducted to preview the thoughts and expectations of specialty physicians who would be expected to be among the first customers of biosimilars, with the objective of gaining insight into some of the major factors that could influence market uptake.• Based on this representative sample of physicians, the overall adoption of biosimilars can be expected to experience widespread uptake in light of anticipated access to comparable therapeutic options at a lower cost versus high-cost biologics. Main factors with the potential to influence the rate and extent of uptake include cost, safety and efficacy data including testing in specific patient populations, and reputation of the manufacturer.• Potential skepticism may be overcome with the help of convincing noninferiority clinical data for products from reputable companies highly experienced with biologics. Educational programs deemed to be unbiased that convey this data could help increase awareness and boost physician confidence in biosimilar products. Source: Frost & Sullivan analysis. NA7B-52 3

IntroductionObjective Frost & Sullivan assessed physicians’ willingness to prescribe biosimilars in the United States. The objective of this research was to conduct a highly qualitative analysis of a representative sample of practicing specialty physicians in the United States in the spirit of an interactive roundtable discussion. The primary goal was to encourage participants to freely express their opinions and ideas around all aspects of a topic, facilitating a free exchange about how biosimilars will impact their practice and the overall U.S. healthcare market. This research was not intended to produce quantitative data. Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011. NA7B-52 4

MethodologyMethodology The biosimilar research panel consisted of 20 preselected participants and was conducted via online moderated discussion boards over a three-day period (October 11-13, 2011). A series of questions was asked on current topics of interest to specialty physicians as well as pharmaceutical and biotechnology companies. Questions and discussions were designed to gauge both short-term and long-term trends and impacts.Participants The panel consisted of 20 specialty physicians: seven oncologists, seven rheumatologists, and six hematologists. Panel participants were randomly selected from a pool of prescreened, qualified candidates and mainly represented hospitals and independent practices across the United States. Selection of specialty practices was based on the therapy area of those biosimilar agents anticipated to enter the U.S. market in the foreseeable future. Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011. NA7B-52 5

Topics and Themes Biosimilars Panel–Fourth Quarter 2011Physician Prescribing Behavior Regulatory Environment• Perceptions and Adoption Potential • Awareness of Regulatory Issues• Patient Types • Clinical Trial Design• Medical Education • Label RequirementsCustomer Purchasing Behavior Manufacturers• Patient Preferences • Company Awareness• Clinical Trial Recruitment • Company Perceptions• Anticipated Payer Perspective • Geographic Influence Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 6

Physician Prescribing Behavior: Questions Posed to thePanel• How did you first hear about biosimilars?• What is your overall willingness to prescribe biosimilars? o What would be the top three factors impacting your decision to prescribe a biosimilar? o What are your concerns? What is the most important concern? Why? • How do you think these concerns can be overcome?• Which patient types would you be most comfortable prescribing a biosimilar [please specify in terms of experienced patient versus naïve/new patient, disease severity (mild/moderate/severe), treatment goals (curative versus palliative), age, other]? Why? o In general, what is the percentage of naïve versus experienced patients that you treat?• When do you envision this will start to pick up traction and have larger market uptake? Why?• Assuming biosimilars are not substitutable, please explain the process of how you would approach this subject with the patients, e.g. wait for them to ask, offer them choices, prescribe brand or biosimilar first. Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 7

Physician Prescribing Behavior: Questions Posed to thePanel (continued) • How would you define a biobetter? o What is your opinion of biobetters? o Would there be greater comfort in prescribing a biobetter versus a biosimilar? Versus a branded product? Why? • Would education programs help make you feel less hesitant to prescribe biosimilars? o What types of education programs would you like to see and for whom (doctors, patients, payers, pharmacists, etc.)? o What would you look for in an education program? o What delivery formats for new drug information do you trust/use the most: (spontaneously, then probe: manufacturer’s Web site, online medical information provider, by a physician-peer, by a pharmaceutical sales representative, paper- based brochures, mobile applications, by a third-party sales organization)? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 8

Customer Purchasing Behavior: Questions Posed to thePanel • What percentage of your patients generally prefers branded drugs over generic drugs? Do you expect similar results with biosimilars versus branded drugs? Why or why not? • Would you enroll a patient to participate in a biosimilar clinical trial in the United States if the branded drug is available to treat them? Why or why not? • Do you foresee recruitment issues in general for biosimilar trials? If so, how do you feel these issues could be overcome? • What concerns do you anticipate from your patients if they are prescribed a biosimilar? What would you likely do to ease these concerns? o What types of help would you like to have from the industry or manufacturers to address patient concerns and why? • What do you think the discount will be for biosimilars versus branded drugs and why? o Do you think this will be enough to sway patients to take a biosimilar versus a branded drug? If not, what do you feel the discount would need to be to start appealing to patients? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 9

Customer Purchasing Behavior: Questions Posed to thePanel (continued) •What reimbursement rate do you expect going forward with biosimilars? Do you expect a high cost for physicians and/or patients? Why or why not? •What concerns do you foresee with payers including biosimilars on their formularies and why? •What reimbursement timeline (from prescription to being reimbursed) would be appropriate for your practice and why? oWould a faster reimbursement turnaround for a biosimilar versus innovator product (due to lesser cost for the payer) lead you to prescribe one over the other? Why or why not? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 10

Customer Purchasing Behavior: Key FindingsAccording to the panel, adoption of biosimilars by payers and patients is expected to be influenced mainlyby cost, with brand perception playing a secondary role for patients. • Biosimilars are expected to be priced from 30 percent to 50 percent below their branded counterparts. • Payers are expected to consider the cost benefit alone when updating formularies. Cost • Financial incentives passed along from payer to physician will likely have a strong influence on some, but not all, physicians. • Immediate and long-term financial benefits for patients and the healthcare system in general is thought to be enough incentive to participate in biosimilar clinical trials. • It appears that the majority of patients are mainly influenced by financial incentives and generally prefer generic drugs to higher-priced branded drugs. Brand Perception • This trend is expected to carry over to biosimilars, but may depend on patients’ perceptions of biologics versus conventional drugs. Source: Frost & Sullivan Analysis. NA7B-52 11

Customer Purchasing Behavior Most patients prefer low-cost generics over brand-name drugsKey Takeaways:• While physicians report patient preferences ranging from most prefer branded drugs to lower cost generics, the most common response leaned toward patient preference for the lower-cost option.• Physicians were divided as to how well this attitude will translate to biosimilars. Factors that may influence patient preference are out-of-pocket costs and perceptions of biologics versus conventional drugs.• Many physicians report that their patients do not have personal preference but rather rely on their advice.Selected Quotes:“About 75 percent of my patients have no preference, 10 percent will want the branded medications only and15 percent will ask if there was a generic they would prefer it for economic reasons; I suspect this will be thesame with biosimilars as long as the patient has to contribute some funds. If both are fully covered without adifferential co-pay, the majority will want branded medications.” (Oncologist, Michigan)“Currently, I see a shift toward generics due to lower co-pays, for pills. I doubt that this will be the same forbiologics, since patients consider them „very strong‟ and they may be afraid to use a generic.”(Rheumatologist, New York)“I have not encountered that situation. Patients are quite comfortable with generics particularly when thereare significant price differences. I expect patients to be reasonably comfortable with generic biosimilars.”(Rheumatologist, Pennsylvania) Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011. NA7B-52 12

Customer Purchasing Behavior: RecommendationsStrong clinical data needed to alter perceptions of potential inferiority Recommendations Rationale • Patients may perceive biologics, as opposed to biosimilars, as superior products simply due to their cost, as many people associate price with• Clear explanation of the financial quality. advantages of developing a biosimilar, coupled with strong clinical data to • Positive clinical data from well- support noninferiority, may help to designed clinical trials may also improve any negative perceptions of increase the confidence level of biosimilars. physicians and help alleviate the concern of being forced to prescribe an inferior product. Source: Frost & Sullivan Analysis.NA7B-52 13

Regulatory Environment: Questions Posed to the Panel • Regarding the FDA discussion over the approval pathway for biosimilars, which topics are most interesting for you? Why? o How do you expect this to play out? • When do you expect to see the first biosimilar launch in the United States? o When is the soonest a biosimilar could launch? Please provide best-case and worst-case scenario. Why? o What do you think is the number-one FDA concern that is delaying this process? • What data would you like to see reviewed by regulatory agents before prescribing a biosimilar to a patient? o What type of clinical trial(s) would you like to see conducted prior to approval? Please specify in terms of trial size, trial design (i.e., randomized, open-label versus blinded, etc.), duration of treatment period and follow-up period, and number of trials per drug. • What would you like the biosimilars’ label to include (e.g., interchangeability)? o What must the label include at a minimum? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 14

Biosimilar Manufacturers: Questions Posed to the Panel • Which companies are you aware of that are developing a biosimilar for the United States market? o How did you first learn about these companies and their involvement in biosimilars? • Overall, what is your opinion of each of these companies? o How do you feel about them developing a biosimilar product for the United States market and why? o What is your comfort level with each of the companies listed? o What types of companies do you trust most and why? • What do you generally take into consideration when evaluating companies developing a biosimilar? What is most important to you and why? o Do you feel the location of where a biosimilar is developed or manufactured is an important consideration? Why or why not? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 15

Biosimilar Manufacturers: Questions Posed to the Panel(continued) • In February 2011, Fujifilm Holdings Corporation bought two units of Merck & Co. that make biopharmaceuticals (to target growth in the healthcare industry and make up for declining sales in cameras and film). Samsung also plans to go into the biosimilars manufacturing business through its partnership with Quintiles. Overall, what is your opinion about outlier companies such as Fujifilm and Samsung investing in biosimilars? Do you expect these companies to have a place in the United States market? Why or why not? • Which companies/biosimilars do you think will be most successful in the United States market and why? Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.NA7B-52 16

About Frost & Sullivan 17

Who is Frost & SullivanFrost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth andachieve best-in-class positions in growth, innovation and leadership. The companys GrowthPartnership Service provides the CEO and the CEOs Growth Team with disciplinedresearch and best-practice models to drive the generation, evaluation, and implementationof powerful growth strategies. Frost & Sullivan leverages 50 years of experience inpartnering with Global 1000 companies, emerging businesses and the investmentcommunity from more than 40 offices on six continents.To join our Growth Partnership, please visit http://www.frost.com.NA7B-52 18

What Makes Us Unique Focused on Growth All services aligned on growth to help clients develop and implement innovative growth strategies Industry Continuous monitoring of industries and their convergence, giving clients first Coverage mover advantage in emerging opportunities Global More than 40 global offices ensure that clients gain global perspective to Footprint mitigate risk and sustain long term growth 360 Degree Proprietary TEAM Methodology integrates 7 critical research perspectives to Perspective optimize growth investments Career research and case studies for the CEOs’ Growth Team to ensure Career Best Practices growth strategy implementation at best practice levels Visionary Innovation Close collaboration with clients in developing their research based visionary Partner perspective to drive GILNA7B-52 19

TEAM MethodologyFrost & Sullivan’s proprietary TEAM Methodology ensures that clients have a complete 360 DegreePerspectiveTM from which to drive decision making. Technical, Econometric, Application, and Marketinformation ensures that clients have a comprehensive view of industries, markets, and technology. Real-time intelligence on technology, including emerging technologies, newTechnical R&D breakthroughs, technology forecasting, impact analysis, groundbreaking research, and licensing opportunities. In-depth qualitative and quantitative research focused on timely and criticalEconometric global, regional, and country-specific trends, including the political, demographic, and socioeconomic landscapes. Insightful strategies, networking opportunities, and best practices that can be applied for enhanced market growth; interactions between the client, peers,Application and Frost & Sullivan representatives that result in added value and effectiveness. Global and regional market analysis, including drivers and restraints, marketMarket trends, regulatory changes, competitive insights, growth forecasts, industry challenges, strategic recommendations, and end-user perspectives.NA7B-52 20

Our Global Footprint 40+ OfficesScanning the Globe for Opportunities and InnovationNA7B-52 21

[SAMPLE] Specialty Physicians Discuss Their Opinions of the U.S. Biosimilars Market

by Frost & Sullivan on Feb 03, 2012

Accessibility

Tags

Upload Details

Usage Rights

1 Embed 1

Statistics

[SAMPLE] Specialty Physicians Discuss Their Opinions of the U.S. Biosimilars Market — Presentation Transcript