Biosimilars Prescribing Survey

OMB Control # 0910-0695

Expiration Date: 02-28-2021

Programmer Notes Revised 11-1-2020

Paperwork Reduction Act Statement:  According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.  The time required to complete this information collection from eligibility to completion of the survey is estimated to average 23 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

Department of Health and Human Services (HHS)/ Food and Drug Administration (FDA) Biosimilars Survey

SURVEY QUESTIONS

SECTION I: Current prescribing practice

PROGRAMMER NOTE: For Q2 – Q4, please display blue text in blue on screen.

Q1. In your practice, how do you most often prescribe medicines that are not controlled substances? [Single punch]

Value	Label
01	Written prescriptions or orders
02	Electronic prescriptions or orders
03	Preprinted forms, prescriptions or orders
04	Verbal prescriptions or orders
-99	Refused

Q2. In your practice, what terminology do you most often use in prescribing medicine for your patients? [Single punch]

Value	Label
01	The brand name of the product (e.g., Zofran)
02	The nonproprietary name of the product (e.g., ondansetron )
03	The brand name together with the nonproprietary name (e.g., Zofran (ondansetron)
04	The nonproprietary name along with the name of the drug maker (e.g., ondansetron by Novartis)
05	Other (specify)
-99	Refused

Q3. In your practice, how do you most often identify the medicines you are prescribing to patients? [Single punch]

Value	Label
01	The brand name of the product (e.g., I am treating you with Zofran)
02	The nonproprietary (generic) name of the product (e.g., I am treating you with ondansetron)
03	The brand name of the reference product regardless of whether a generic drug is prescribed (e.g., I am treating you with a generic version of Zofran)
04	The brand name together with the nonproprietary name (e.g., I am treating you with Zofran, also known as ondansetron)
05	The nonproprietary name along with the name of the drug maker (e.g., I am treating you with ondansetron by Novartis)
06	Terms related to the mechanism of action or indication of use (e.g., I am treating you with a medicine that helps prevent nausea)
-99	Refused

Q4. In your experience how do patients most often refer to the medicines they are taking? [Single punch]

Value	Label
01	The brand name of the medicine (e.g., I need a refill for Zofran)
02	The nonproprietary (generic) name of the medicine (e.g., I need a refill for ondansetron)
03	The brand name and nonproprietary name together (e.g., I need a refill for Zofran, or ondansetron)
04	The nonproprietary name along with the name of the drug maker (e.g., I need a refill for Novartis’ ondansetron)
05	Terms related to the mechanism of action or indication of use (e.g., I need a refill for my medicine for nausea)
06	Terms related to the physical characteristics of the medication or packaging (e.g., I need a refill for my blue and yellow pills)
-99	Refused

Q5. For biological medicines, please indicate how biological medicines are obtained and administered to your patients. Please choose all that apply. [Multi punch]

Value	Label
01	I prescribe the biological medicine to patients; they pick the medicine up from a specialty pharmacy and return to a clinic for the medicine to be administered.
02	I prescribe the biological medicine to patients; they pick the medicine up from a specialty pharmacy, and administer the medicine at home.
03	I (or my staff) order biological medicines into my clinic and then administer to the patients during clinic visits.
04	I prescribe the biological medicine to patients; they pick the medicine up from a pharmacy and return to a clinic for the initial doses of the medicine to be administered. Patients may administer subsequent doses at home.
05	I prescribe the biological medicine to patients; they obtain and administer the biological medicines through other means.
06	I prescribe the biological medicine to patients; a specialty pharmacy sends it to an infusion center to be administered to patients.
-99	Refused

Q6. If you (or your staff) procure, store, and administer biological medicines in your clinic or office, how do you generally procure the biological medicines? Please choose all that apply. [Multi punch]

Value	Label
01	For individual patients as the need arises
02	In bulk, to have ready for patients who are likely to present with a need for these medicines
03	A combination of bulk ordering and individual-specific ordering depending on the medicine
04	Not applicable to my practice
-99	Refused

Q7. If you (or your staff) procure, store, and administer medicines in your clinic or office, how do you order specific biological medicines for use in your clinic? Please choose all that apply. [Multi punch]

Value	Label
01	National Drug Code (NDC)
02	Brand name
03	Nonproprietary name
04	Other (please specify)
05	Not sure
06	Not applicable to my practice
-99	Refused

SECTION II: Impressions of biosimilar naming: unaided and aided questions

PROGRAMMER NOTE: For Q8 – Q15, pipe in appropriate information based on provider specialty. Note that the nonproprietary names should appear in parentheses after the brand names. Half of the respondents within each specialty will be randomized to receive the survey with the nonproprietary name for Junexant piped from A1 and other half the nonproprietary name for Junexant will be piped from A2.

Specialty	A1 Junexant (with suffix)		A2 Junexant (without suffix)	B Nexsymeo	C Indication
Rheumatology		denliximab-ghvb	denliximab	denliximab-kbcn	rheumatoid arthritis
Dermatology		denliximab-ghvb	denliximab	denliximab-kbcn	plaque psoriasis
Gastroenterology		denliximab-ghvb	denliximab	denliximab-kbcn	adult Crohn’s Disease
Oncology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	treatment of neutropenia
Hematology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	treatment of neutropenia
Nephrology		esalamin-ghvb	alodripsim	esalamin-kbcn	treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis

Q8. Suppose Junexant ([A1 or A2: pipe in based on specialty and randomization]) is a biological product that is approved for [C: pipe in based on specialty]. Recently, a new biological product Nexsymeo ([B: pipe in based on specialty]) was introduced into the market after receiving FDA approval.

Based only on the information presented above, how certain are you that the new Nexsymeo ([B: pipe in based on specialty]) product and Junexant ([A1 or A2: pipe in based on specialty and randomization]) will …? [Grid]

PROGRAMMER NOTE: Randomize A through F, same order for Q8 and Q9.

Q8A. Have the same active ingredient

Q8B. Have one or more of the same FDA-approved indications in common

Q8C. Have common route(s) of administration

Q8D. Have the same expected clinical performance (i.e., safety and efficacy)

Q8E. Have the same mechanism of action

Q8F. Have the same dosing

Value	Label
01	Completely certain
02	Very certain
03	Somewhat certain
04	Not certain at all
-99	Refused

Q9. Assume you prescribe Junexant ([A1 or A2: pipe in based on specialty and randomization]) frequently in your practice. You research the new Nexsymeo ([B: pipe in based on specialty]) product, which is approved by the FDA as a biosimilar to Junexant for ([C: pipe in based on specialty]) . “Biosimilar” means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. A biosimilar product must also have the same strength, route of administration, and dosage form as the reference product, and its conditions of use (e.g., indications) must have been previously approved for the reference product.

In order for your patients to receive the biosimilar product, you must expressly prescribe “[B: pipe in based on specialty]” or Nexsymeo.

Considering the information above, how certain are you that the new Nexsymeo ([B: pipe in based on specialty]) product and Junexant ([A1 or A2: pipe in based on specialty and randomization]) will…? [Grid]

PROGRAMMER NOTE: Randomize A through F, same order for Q8 and Q9.

Q9A. Have the same active ingredient

Q9B. Have one or more of the same FDA-approved indications in common

Q9C. Have common route(s) of administration

Q9D. Have the same expected clinical performance (i.e., safety and efficacy)

Q9E. Have the same mechanism of action

Q9F. Have the same dosing

Value	Label
01	Completely certain
02	Very certain
03	Somewhat certain
04	Not certain at all
-99	Refused

//NEW SCREEN//

For the following set of questions, you will be presented with a set of treatment scenarios. For each, we ask that you consider the information presented as you make your decision about which drug therapy you would prescribe. When choosing your answers, we urge you to respond as if you were actually selecting a drug for a patient.

PROGRAMMER NOTE: For Q10-Q15, piped values should be labeled as A1: Junexant with suffix, A2: Junexant without suffix, and B: Nexsymeo

Use table below for Q10–Q11.

Specialty	A1 Junexant) (with suffix)		A2 Junexant (without suffix)	B Nexsymeo	D New Patient Scenario
Rheumatology		denliximab-ghvb	denliximab	denliximab-kbcn	Your new patient with rheumatoid arthritis: Is symptomatic with moderately active disease Would benefit from treatment with a TNF inhibitor
Dermatology		denliximab-ghvb	denliximab	denliximab-kbcn	Your new patient has: Chronic and severe plaque psoriasis Is a good candidate for systemic therapy with a TNF inhibitor
Gastroenterology		denliximab-ghvb	denliximab	denliximab-kbcn	Your new adult patient with moderately active Crohn’s disease: Has had an inadequate response to conventional therapy Would benefit from a TNF inhibitor
Oncology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	Your new patient with cancer: Is neutropenic following treatment with chemotherapy She needs treatment in order to continue chemotherapy
Hematology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	Your new patient with cancer: Is neutropenic following treatment with chemotherapy She needs treatment in order to continue chemotherapy
Nephrology		esalamin-ghvb	esalamin	esalamin-kbcn	Your adult patient with end-stage renal disease requiring hemodialysis: Has a hemoglobin level that would be appropriate for treatment with an erythropoiesis stimulating agent

//NEW SCREEN//

Q10. [D: pipe in based on specialty] Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before	Recently introduced; you have not prescribed it before
Formulary status:	On formulary	On formulary
Method of Delivery:	Same
Indications:	Same

In this situation I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

Q11. Now, again consider the same new patient and products, except now the formulary lists Nexsymeo ([B: pipe in based on specialty]), not Junexant ([A1 or A2: pipe in based on specialty and randomization]). Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before	Recently introduced; you have not prescribed it before
Formulary status:	NOT on formulary; higher out-of-pocket for patient	On formulary; lower out-of-pocket for patient
Method of Delivery:	Same
Indications:	Same

In this situation, I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

PROGRAMMER NOTE: Use table below for Q12-Q13.

Specialty	A1 Junexant (with suffix)	A2 Junexant (without suffix)	B Nexsymeo	E Existing Patient Scenario
Rheumatology	denliximab-ghvb	denliximab	denliximab-kbcn	Has rheumatoid arthritis Is symptomatic with moderately active disease Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well This patient would benefit from an anti-TNF inhibitor
Dermatology	denliximab-ghvb	denliximab	denl.iximab-kbcn	Has chronic and severe plaque psoriasis Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well This patient would benefit from an anti-TNF inhibitor
Gastroenterology	denliximab-ghvb	denliximab	denliximab-kbcn	Has moderately active Crohn’s disease Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well This patient would benefit from an anti-TNF inhibitor
Oncology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	Is neutropenic following treatment with chemotherapy The patient was treated with Junexant (alodripstim-ghvb) during a previous cycle of chemotherapy, and tolerated the therapy well The patient needs treatment in order to continue chemotherapy
Hematology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	Is neutropenic following treatment with chemotherapy The patient was treated with Junexant (alodripstim-ghvb) during a previous cycle of chemotherapy, and tolerated the therapy well The patient needs treatment in order to continue chemotherapy
Nephrology	esalamin-ghvb	esalamin	esalamin-kbcn	Has end-stage renal disease requiring hemodialysis Has a hemoglobin level that would be appropriate for treatment with an erythropoiesis stimulating agent The patient has been treated with Junexant (alodripsim-ghvb) previously and tolerated it well

Q12. Next, please consider an existing patient who: [E: pipe in based on specialty] Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before to this patient.	Recently introduced; you have not prescribed it before to this patient
Formulary status:	On formulary	On formulary
Method of Delivery:	Same
Indications:	Same

In this situation I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

Q13. Now, consider the same existing patient and products, except now the formulary lists Nexsymeo ([B: pipe in based on specialty]), not Junexant ([A1 or A2: pipe in based on specialty and randomization]). Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before to this patient	Recently introduced; you have not prescribed it before to this patient
Formulary status:	NOT on formulary; higher out-of-pocket for patient	On formulary; lower out-of-pocket for patient
Method of Delivery:	Same
Indications:	Same

In this situation I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

PROGRAMMER NOTE: Use table below for Q14.

Specialty	A1 Junexant (with suffix)	A2 Junexant (without suffix)	B Nexsymeo	F Junexant Presentations	G Nexsymeo Presentation
Rheumatology	denliximab-ghvb	denliximab	denliximab-kbcn	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe or auto-injector	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe
Dermatology	denliximab-ghvb	denliximab	denliximab-kbcn	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe or auto-injector	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe
Gastroenterology	denliximab-ghvb	denliximab	denliximab-kbcn	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe or auto-injector	IV infusion: Single-dose vial Subcutaneous injection: prefilled syringe
Oncology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	IV infusion : Single-dose vial Subcutaneous injection: prefilled syringe or single-dose vial	IV infusion : Single-dose vial Subcutaneous injection: Single-dose vial
Hematology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	IV infusion : Single-dose vial Subcutaneous injection: prefilled syringe	IV infusion : Single-dose vial Subcutaneous injection: Single-dose vial
Nephrology	esalamin-ghvb	esalamin	esalamin-kbcn	IV infusion : Single-dose vial Subcutaneous: prefilled syringe or single-dose vial	IV infusion : Single-dose vial Subcutaneous injection: Single-dose vial

Q14. Now, consider the same existing patient and products, except that one product has fewer approved presentations (i.e. method of delivery). Both medications are approved for the same indications and approved for the same routes of administration. Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before	Recently introduced; you have not prescribed it before
Formulary status:	On formulary	On formulary
Method of Delivery:	[F: pipe in based on specialty]	[G: pipe in based on specialty]
Indications:	Same

In this situation I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

PROGRAMMER NOTE: Use table below for Q15.

Specialty	A1 Junexant (with suffix		A2 Junexant (without suffix)	B Nexsymeo	H Junexant Indication	J Nexsymeo Indication
Rheumatology		denliximab-ghvb	denliximab	denliximab-kbcn	Rheumatoid Arthritis Juvenile Idiopathic Arthritis Psoriatic Arthritis	Rheumatoid Arthritis
Dermatology		denliximab-ghvb	denliximab	denliximab-kbcn	Plaque Psoriasis Hidradenitis Suppurativa Uveitis	Plaque Psoriasis
Gastroenterology		denliximab-ghvb	denliximab	denliximab-kbcn	Adult Crohn’s Disease Pediatric Crohn’s Disease Ulcerative Colitis	Adult Crohn’s Disease
Oncology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	Treatment of neutropenia Mobilization of stem cells	Treatment of neutropenia
Hematology		alodripsim-ghvb	alodripsim	alodripsim-kbcn	Treatment of neutropenia Mobilization of stem cells	Treatment of neutropenia
Nephrology		esalamin-ghvb	esalamin	esalamin-kbcn	Treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis Reduction of allogeneic blood transfusion in surgery patients	Treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis

Q15. Now, consider the same existing patient and products, except that one product has fewer approved indications. Both medications are approved for the indication your patient presents with and have the same routes of administration. Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]

Biologic:	Junexant ([A1 or A2: pipe in based on specialty and randomization])	Nexsymeo ([B: pipe in based on specialty])
Prescription history:	You have prescribed it before	Recently introduced; you have not prescribed it before
Formulary status:	On formulary	On formulary
Method of Delivery:	Same
Indications:	[H: pipe in based on specialty]	[J: pipe in based on specialty]

In this situation I would prescribe:

Value	Label
01	Junexant ([A1 or A2: pipe in based on specialty and randomization])
02	Nexsymeo ([B: pipe in based on specialty])
-99	Refused

PROGRAMMER NOTE: Use table below for Q16.

Specialty	A1 Junexant (with suffix)	A2 Junexant (without suffix)	B Nexsymeo	K Therapy type
Rheumatology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Dermatology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Gastroenterology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Oncology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	alodripsim
Hematology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	alodripsim
Nephrology	esalamin-ghvb	esalamin	esalamin-kbcn	esalamin

Q16. Imagine your institution or patient’s formulary recently added the biosimilar Nexsymeo ([B: pipe in based on specialty]) as a preferred product on formulary instead of Junexant ([A1 or A2: pipe in based on specialty and randomization]). For each of the following patients, indicate how likely you would be to pursue a prior authorization or formulary exception for treatment with Junexant ([A1 or A2: pipe in based on specialty and randomization]) instead of Nexsymeo ([B: pipe in based on specialty]). [Grid]

Q16A. Patients new to [A1 or A2: pipe in based on specialty and randomization].

Q16B. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with no tolerability issues.

Q16C. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with minor tolerability issues.

Q16D. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with moderate to major tolerability issues.

Value	Label
01	Very likely
02	Likely
03	Neither likely nor unlikely
04	Unlikely
05	Very unlikely
-99	Refused

Q17. Please indicate how strongly each consideration would influence your willingness to try the new biosimilar Nexsymeo ([B: pipe in based on specialty]) for your patients. [Grid]

[Randomize A through L; “Other” appears last]

Q17A. Recommendations of colleagues in your field.

Q17B. Education on the type of information and analysis the FDA uses to conclude products are highly similar, including the availability of summaries that describe the analytic and clinical evidence used in the approval of this particular product.

Q17C. Confidence in specific, timely and accurate pharmacovigilance to monitor the safety of these products.

Q17D. Clarity of the labeling and package insert.

Q17E. Differences between the nonproprietary names of the biosimilar and reference products.

Q17F. The ability to identify which product is dispensed to the patient.

Q17G. Financial savings to the patient.

Q17H. Financial implications to me/my practice related to insurance reimbursement rates.

Q17I. Prior authorization (e.g. paperwork required for the patient to receive therapy).

Q17J. The patient experience with Junexant ([A1 or A2: pipe in based on specialty and randomization]).

Q17K. Patients’ interest in trying a biosimilar similar to Junexant ([A1 or A2: pipe in based on specialty and randomization).

Q17L. Institutional preference.

Q17M. Varying clinical situations.

Other; please describe what other factors would influence your decision making:

Q17M1. Factor 1:________________________________

Q17M2. Factor 2:­­­­­­­­­­­­­­­­­­­________________________________

Q17M3. Factor 3:­­­­­­­­­­­­­­­­­­­________________________________

[Participants should be able to rate influence level for any “other” entries.]

Value	Label
01	1 - No influence at all
02	2
03	3
04	4
05	5 – Strong influence
-99	Refused

Q17BIO. Please indicate how strongly you agree or disagree with the following statement:

I would never prescribe a biosimilar. [Single Punch]

Value	Label
01	Strongly agree
02	Agree
03	Neither agree nor disagree
04	Disagree
05	Strongly disagree
-99	Refused

Q18. Please indicate how strongly you agree or disagree with the following items: [Grid]

[Randomize A through G]

Q18A. I answered the questions as if I were actually prescribing these biologics.

Q18B. I prefer to prescribe products I have experience prescribing, rather than new products.

Q18C. I am less likely to prescribe biosimilar products than reference biologics.

Q18D. I anticipate biosimilar products will be less expensive for my patients.

Q18E. I am waiting until biosimilar products have been on the market longer before I prescribe them.

Q18F. I am more likely to prescribe biosimilar products than reference biologics.

Q18G. In general, for my patients, I specify “Dispense as Written” to ensure dispensing of the intended biological product.

Value	Label
01	Strongly agree
02	Agree
03	Neither agree nor disagree
04	Disagree
05	Strongly disagree
-99	Refused

SECTION III: Overall Impressions of Naming Scheme

[Randomize order of Q19, 20]

Q19. How often is it reported to you that a patient received a different medicine than the one you had intended? [Single punch]

Value	Label
01	Always
02	Frequently
03	Occasionally
04	Seldom
05	Never
06	Don’t know
-99	Refused

Q20. Suffixes incorporated in nonproprietary names of biological products… [Grid]

Q20A. Allow me to ensure my patient gets the product I intended.

Q20B. Facilitate tracking any adverse events to a specific product.

Q20C. Make prescribing burdensome.

Q20D. Make prescribing confusing.

Value	Label
01	Strongly agree
02	Agree
03	Neither agree nor disagree
04	Disagree
05	Strongly disagree
06	Don’t know
-99	Refused

SECTION IV: Impact of Biological Naming on Communication

PROGRAMMER NOTE: Use table below for Q21–Q23.

Specialty	A1 Junexant (with suffix)	A2 Junexant (without suffix)	B Nexsymeo	K Therapy type
Rheumatology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Dermatology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Gastroenterology	denliximab-ghvb	denliximab	denliximab-kbcn	denliximab
Oncology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	alodripsim
Hematology	alodripsim-ghvb	alodripsim	alodripsim-kbcn	alodripsim
Nephrology	esalamin-ghvb	esalamin	esalamin-kbcn	esalamin

Q21. In your practice, what terminology would you anticipate using most often to prescribe biosimilar biological products? Select one. [Single punch]

[Randomize A through F; G (“Other”) appears last]

Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.

Value	Label
01	The brand name of the product you want your patient to receive if the product has one (e.g., Junexant, Nexsymeo).
02	The nonproprietary name of the product including the suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).
03	The nonproprietary name of the product excluding the suffix (e.g., [K: pipe in based on specialty]).
04	Both the brand name, if the product has a brand name, and nonproprietary name, including suffix (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty]).)
05	The drug substance name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).
06	The brand name of the reference product (e.g., Junexant or “a biosimilar to Junexant”).
07	Other (please describe)
-99	Refused

Q22. As more biosimilar biological products are introduced, how do you anticipate that you or your staff will record the name of the prescribed medicine in the patient health record? [Single punch]

[Randomize A through E; F (“Other”) appears last]

Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.

Value	Label
01	The brand name of the product you prescribed, if the product has one (e.g., Junexant or Nexsymeo).
02	The nonproprietary name of the product including any suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).
03	The nonproprietary name of the product excluding any suffix (e.g., [K: pipe in based on specialty]).
04	Both the brand name, if the product has a brand name, and nonproprietary name (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty])).
05	The nonproprietary name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).
06	Other
-99	Refused

Q23. As more biosimilar biological products are introduced, how do you anticipate that you or your staff will record the names of biological medicines administered at your office or clinic in the patient health record? [Single punch]

[Randomize A through E; F (“Other”) and G (“Not applicable”) appear last]

Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.

Value	Label
01	The brand name of the product you prescribed, if the product has one (e.g., Junexant or Nexsymeo).
02	The nonproprietary name of the product including any suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).
03	The nonproprietary name of the product excluding any suffix (e.g., [K: pipe in based on specialty]).
04	Both the brand name, if the product has a brand name, and nonproprietary name (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty])).
05	The nonproprietary name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).
06	Other
07	Not applicable (Neither my staff nor I administer medicines)
-99	Refused

Q24. Have you ever prescribed a biosimilar? Examples of FDA-approved biosimilars currently on the market are Renflexis (infliximab-abda), Inflectra (infliximab-dyyb), Zarxio (filgrastim-sndz), Retacrit (epoetin alfa-epbx), and Fulphila (pegfilgrastim-jmdb). [Single punch]

Value	Label
01	Yes
02	No
03	Unsure
-99	Refused

Closing/Debrief

Thank you for your participation in this study; we appreciate your time and effort. Your participation helps the U.S. Department of Health and Human Services and FDA learn more about how health care providers think and communicate about biosimilar drug products.

The drug names that you saw today were created for the purposes of this study and are not for real prescription drugs.