UDENYCA®
Product Summary
QUICK INFO ACCESS
Supporting you in delivering optimal patient care
From NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): G-CSF primary prophylaxis supports optimal dose intensity and clinical outcomes1
When FN risk is >20%, G-CSF prophylaxis*1:
Reduced the risk of FN1
(RR: 0.54; 95% CI, 0.43–0.67)
Significantly improved the relative dose intensity (RDI) of chemotherapy with an average difference in RDI of 8.4%1
(G-CSF-treated patients vs non-G-CSF-treated patients)
G-CSF was shown to increase RDI and is associated with survival benefit†1
Important considerations
*Results from a systematic review of 17 randomized trials, which included 3493 patients with solid tumors and lymphoma. G-CSF included filgrastim and pegfilgrastim.
†Survival benefit not included in UDENYCA® prescribing information.
Reference: 1. Kuderer, M. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia. J Clin Oncol. 2007;25(21):1-10
CI = confidence interval; FN = febrile neutropenia; G-CSF = granulocyte colony stimulating factor; RR = relative risk.
UDENYCA® was confirmed to be highly similar to Neulasta®, with no clinically meaningful differences2-4
Over 30 attributes and 26 analytical methods were used to ensure that FDA quality benchmarks were met for biosimilarity4
*The assays used to assess immunogenicity for UDENYCA® were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects.
*The assays used to assess immunogenicity for UDENYCA® were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects.
PATIENT PREFERENCE SURVEY
Do your patients prefer to return to the clinic for next-day pegfilgrastim product administration?
A patient survey evaluated preference for pegfilgrastim product administration and value of next-day visits4
Select demographics
Sex: 59% female, 41% male
Top 3 cancer types: breast (31%), NSCLC (16%), prostate (12%)
Full-time employed: 59%
Distance to clinic: 63% of patients live within 25 miles; 10% live within 50–100 miles; 3% live >100 miles
Note: Where appropriate, statistical differences between patient groups were tested at a 90%–95% CI.
Survey limitations: Retrospective survey; only one group had experience with both PFS and OBI devices. Subgroups were not matched with patient cancer types or chemotherapy treatments. Results reflect the opinion of patients and are not intended to be used as clinical support. Sponsored by Coherus BioSciences, Inc.
CI = confidence interval; NSCLC = non-small cell lung cancer; OOP = out-of-pocket.
Survey design4
- Online, double-blinded survey conducted in 275 adult patients receiving myelosuppressive chemotherapy within the last 90 days
- Survey fielded 02/08/21–03/02/21
- 3 patient groups: Prefilled syringe (PFS) users, on-body injector (OBI) users, patients experienced with both PFS and OBI
Survey key objectives4
- Understand patient preference for pegfilgrastim administration and the value of next-day visits
- Determine desired level of patient involvement in their pegfilgrastim decision
- Understand impact of travel distance
- Evaluate the influence of OOP costs
Note: Where appropriate, statistical differences between patient groups were tested at a 90%-95% CI.
Survey limitations: Retrospective survey; only one group had experience with both PFS and OBI devices. Subgroups were not matched with patient cancer types or chemotherapy treatments. Results reflect the opinion of patients and are not intended to be used as clinical support. Sponsored by Coherus BioSciences, Inc.1
CI = confidence interval; NSCLC = non-small cell lung cancer; OOP = out-of-pocket.
SURVEY RESULTS
Next-day visits to the clinic may increase patient comfort
Among patients experienced with both PFS and OBI (n=56)4:
*Vs 60% of OBI users (n=106); significant at 90% CI. Percentages reflect patients strongly agreeing/agreeing with the statement “I prefer to come back to the office the next day to get my pegfilgrastim administered by my HCP.”
†Vs 73% OBI users (n=106); significant at 90% CI. Percentage reflects patients strongly agreeing/agreeing with the statement “I feel well monitored for side effects related to my cancer treatment if I come back to the office the day after chemotherapy for my pegfilgrastim injection.”
‡Vs 62% of OBI users; significant at 90% CI. Percentages reflect patients strongly agreeing/agreeing with the statement “I feel more at ease if my pegfilgrastim is administered in-person by my HCP.”
§Vs 62% of OBI users; significant at 95% CI. Percentages reflect patients strongly agreeing/agreeing with the statement “I believe the quality of my care increases if I come back to the office the day after chemotherapy for my pegfilgrastim injection.”
CI = confidence interval; OBI = on-body injector; PFS = prefilled syringe.
SURVEY RESULTS
A majority of patients are willing to travel, especially for the lowest-cost option
Of patients surveyed (n=275)4:
would prefer the lowest-cost pegfilgrastim product option
even if it means returning to the office the next day
prefer to be involved in choosing their pegfilgrastim product option
with their HCP*
- 92% of all patients are able to return the day after chemotherapy, if needed4
* Percentage reflects patients answering extremely/very involved to the following question: “If you were given a choice, how involved would you like to be choosing which pegfilgrastim you receive?”
RECOMMENDING THE APPROACH THAT’S RIGHT FOR YOUR PATIENTS
Some considerations for assessing patient preference for prefilled syringe (PFS) or on-body injector (OBI)
CONFIDENCE IN CARE WITH PEGFILGRASTIM
UDENYCA® PFS: Administered once per cycle
Single-dose prefilled subcutaneous injection of 6 mg administered once per chemotherapy cycle
Do not administer UDENYCA® between 14 days before and 24 hours after administration of cytotoxic chemotherapy
See full Prescribing Information for full dosing instructions
What type of resources would be most effective for your patients and practice?
Choose one answer:
decide between PFS and OBI
program
Thank you for your response.
Your answer will be used to help us better understand treatment resource needs with respect to UDENYCA®.
OBI = on-body injector; PFS = prefilled syringe.
Which statement most accurately reflects your current view on biosimilars?
Choose one answer:
are safe and effective
of biologics over
biosimilars due
to familiarity and experience
branded biologic or biosimilar
biosimilars before deciding
what
my preference is
Thank you for your response.
Your answer will be used to help us better understand treatment and resource needs with respect to biosimilars.
Thank you for viewing this UDENYCA® presentation
Please take a moment to share your expert opinion. Information will be used to help assess treatment and resource needs for healthcare professionals and their patients.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 30, 2022. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. UDENYCA® (pegfilgrastim-cbqv) Prescribing Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 3. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen Inc.; 2021. 4. Data on file. Coherus BioSciences, Inc.; 2023.
UDENYCA is a registered trademark of Coherus BioSciences, Inc. ZIEXTENZO is a registered trademark of Novartis AG. Fulphila is a registered trademark of Mylan Institutional Inc. Neulasta is a registered trademark of Amgen Inc. Nyvepria is a trademark of Pfizer Inc.
© 2023 Coherus BioSciences, Inc. All rights reserved. 1221‑UDY‑P569