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 differences^2-4

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.

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

Mean age: 47 years
Sex: 59% female, 41% male
Top 3 cancer types: breast (31%), NSCLC (16%), prostate (12%)
Full-time employed: 59%

Commercial insurance: 75%
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

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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.

G-CSF

Biosimilarity

Patient Preference

Decision Tool

UDENYCA® Dosing

INDICATION

UDENYCA^® (pegfilgrastim-cbqv) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA^® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA^® in patients with ARDS.

Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA^® in patients with serious allergic reactions.

Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA^® if sickle cell crisis occurs.

Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA^® if causality is likely.

Leukocytosis: White blood cell (WBC) counts of 100 x 10⁹/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA^® therapy is recommended.

Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.

Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA^® if aortitis is suspected.

Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1‑800‑4‑UDENYCA (1‑800‑483‑3692) or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

G-CSF expanded use during COVID-19 pandemic

As a result of the current COVID-19 pandemic, the National Comprehensive Cancer Network^® (NCCN^®) and American Society of Clinical Oncology (ASCO^®) have offered short-term recommendations specific to issues with COVID-19 (SARS-CoV-2) for hematopoietic growth factors, as related to the on-label use of our product. The recommendations include the expanded prophylactic use of granulocyte colony-stimulating factor (G-CSF), such as pegfilgrastim, to reduce the potential number and length of hospitalizations for cancer patients undergoing various chemotherapy treatments. Please see important limitations to these recommendations outlined below.

UPDATED RECOMMENDATIONS

The short-term recommendations include a lowered threshold for the use of myeloid growth factors from those chemotherapy regimens that have a 20% or higher risk of febrile neutropenia to now include those regimens with a 10%-20% risk of febrile neutropenia, which includes all of the intermediate risk chemotherapy regimens.^1,2

CAUTION: Physicians may wish to avoid use of or discontinue G-CSF in cases of respiratory infection, respiratory symptoms, or confirmed or suspected COVID-19 to avoid increase in pulmonary inflammation or hypothetical risk of increasing inflammatory cytokines associated with adverse outcome.

For further information from each organization:

NCCN is providing resources from the leading cancer centers that comprise the nonprofit alliance and sharing them all online at NCCN.org/covid-19. The site will be updated as new resources become available. For information specifically on changes to the myeloid growth factors guidelines, please see NCCN.org/covid-19/pdf/HGF_COVID-19.pdf.

ASCO has provided guidance on how to care for patients experiencing potential neutropenic fever and neutropenia who are affected by the ongoing COVID-19 pandemic. This guidance can be found online at ASCO.org.

If you have any questions on these guidelines, please call our Medical Affairs team at 1-800-483-3692.

References: 1. Referenced with permission from the National Comprehensive Cancer Network, Inc. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed April 9, 2020. To view the most recent and complete version of the guideline, 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. COVID‑19 patient care information. American Society of Clinical Oncology (ASCO). Updated April 23, 2020. Accessed May 1, 2020. https://www.asco.org/asco-coronavirus-information/care-individuals-cancer-during-covid-19

UDENYCA® Product Summary

QUICK INFO ACCESS

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

G-CSF expanded use during COVID-19 pandemic

UPDATED RECOMMENDATIONS

For further information from each organization:

UDENYCA^®
Product Summary