[SAMPLE] Specialty Physicians Discuss Their Opinions of the United States Biosimilars Market

Specialty Physicians Discuss Their Opinions of

the United States Biosimilars Market

Insights into the

Potential Reactions of Key Customers and Influence on Market Uptake

December 2011

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Contents

Section 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

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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.

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Introduction

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.

Objective

Source: Frost & Sullivan Biosimilar Discussion Board, Fourth Quarter 2011.

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Methodology

Methodology

Participants

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.

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.


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Topics and Themes

Biosimilars Panel–Fourth Quarter 2011

Physician Prescribing Behavior

• Perceptions and Adoption Potential

• Patient Types

• Medical Education

Customer Purchasing Behavior

• Patient Preferences

• Clinical Trial Recruitment

• Anticipated Payer Perspective

Regulatory Environment

• Awareness of Regulatory Issues

• Clinical Trial Design

• Label Requirements

Manufacturers

• Company Awareness

• Company Perceptions

• Geographic Influence


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Physician Prescribing Behavior: Questions Posed to the

Panel

• 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.


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Physician Prescribing Behavior: Questions Posed to the

Panel (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)?

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• 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?

Customer Purchasing Behavior: Questions Posed to the

Panel


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•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?

Customer Purchasing Behavior: Questions Posed to the

Panel (continued)


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Customer Purchasing Behavior: Key Findings

Cost

• 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.

• 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.

Brand Perception

According to the panel, adoption of biosimilars by payers and patients is expected to be influenced mainly

by cost, with brand perception playing a secondary role for patients.

• It appears that the majority of patients are mainly influenced by financial

incentives and generally prefer generic drugs to higher-priced branded drugs.

• This trend is expected to carry over to biosimilars, but may depend on patients’

perceptions of biologics versus conventional drugs.

Source: Frost & Sullivan Analysis.

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Customer Purchasing Behavior Most patients prefer low-cost generics over brand-name drugs

Key Takeaways:

“About 75 percent of my patients have no preference, 10 percent will want the branded medications only and

15 percent will ask if there was a generic they would prefer it for economic reasons; I suspect this will be the

same with biosimilars as long as the patient has to contribute some funds. If both are fully covered without a

differential 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 for

biologics, 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 there

are significant price differences. I expect patients to be reasonably comfortable with generic biosimilars.”

(Rheumatologist, Pennsylvania)

• 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:


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Customer Purchasing Behavior: Recommendations Strong clinical data needed to alter perceptions of potential inferiority

Source: Frost & Sullivan Analysis.

Recommendations

• Clear explanation of the financial

advantages of developing a biosimilar,

coupled with strong clinical data to

support noninferiority, may help to

improve any negative perceptions of

biosimilars.

Rationale

• Patients may perceive biologics, as

opposed to biosimilars, as superior

products simply due to their cost, as

many people associate price with

quality.

• Positive clinical data from well-

designed clinical trials may also

increase the confidence level of

physicians and help alleviate the

concern of being forced to prescribe

an inferior product.

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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?


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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?


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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?


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About Frost & Sullivan

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Who is Frost & Sullivan

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community from more than 40 offices on six continents.

To join our Growth Partnership, please visit http://www.frost.com.

http://www.frost.com/

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[SAMPLE] Specialty Physicians Discuss Their Opinions of the United States Biosimilars Market

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