Biosimilars create
competition for change

The rising cost of treatment continues to remain
at the forefront of physician and patient concerns.

Biosimilars offer choice

Biosimilars can drive down the cost of care while delivering quality treatment to those who need it. As high-value biosimilar competition continues to enter the market, providers are realizing the power of choice.

Projected annual savings from biosimilars alone are expected to top $60 billion in 2023 for a 5-year total of $153 billion¹
Savings will benefit a range of stakeholders in the short term, with patients, payers, and the healthcare system seeing potential long-term benefits¹

Coherus BioSciences was established in 2010 with the mission to improve patient access to high-quality biologics for life-altering diseases by leveraging the biosimilar regulatory pathway.

Benefits of biosimilars

PROVIDERS^1,2

Provides a choice that has the potential to lower the financial burden
May help increase patient access

PATIENTS^1,2

Helps decrease overall financial burden
Increases access to treatment options

SYSTEM^1,2

Offsets the burden of increasing healthcare costs in areas such as oncology
Potential savings due to more treatment choices and increased competition
May free up resources for other important aspects of healthcare

The need for UDENYCA^®

Lack of competition enabled cost increases. Wholesale acquisition cost (WAC)
of Neulasta^® (pegfilgrastim) has more than doubled since 2006.³

Patients and payers share the cost burden

Although Centers for Medicare & Medicaid Services (CMS) and insurers have taken on a greater share of the increasing costs, patients also share in this cost burden through larger co-pay and co-insurance premiums. Increasing costs reduce access for patients who may have difficulties paying for supportive care.⁴

UDENYCA^® offers a choice

Availability of a biosimilar introduces competition and helps control costs while delivering quality supportive care to patients who need it.⁵

UDENYCA^® offers significant cost
savings for your practice⁶

Wholesale acquisition cost (WAC)*

$6417

Neulasta^®

$4175

UDENYCA^®

UDENYCA^® delivers high-quality treatment and the reliable outcomes you expect with Neulasta^®, but with 35% cost savings per dose.^*6

UDENYCA^® was confirmed
to be highly similar to
Neulasta^®, with no clinically
meaningful differences.^7-9

View proven biosimilarity

Receive occasional emails to learn more about UDENYCA^®, reimbursement, and support services for your chemotherapy patients.

* Based on WAC. WAC does not necessarily reflect actual prices paid by consumers, pharmacies, or third-party payers. UDENYCA^® WAC of $4175 per prefilled syringe vs Neulasta^® WAC of $6417 per prefilled syringe.

References: 1. Biosimilars market is ripe for cost savings. The Center for Biosimilars. Published June 27, 2019. Accessed September 20, 2022. 2. Biosimilars: a safe & effective option for patients. The Biosimilars Council. Updated January 2018. Accessed September 20, 2022. http://biosimilarscouncil.org/wp-content/uploads/2017/11/Biosimilars-Fact-Sheet_Updated-10-9-17-Final.pdf. 3. US Bureau of Labor Statistics. Medi-Span Price Rx, 2022. 4. Meropol NJ, Schulman KA. Cost of cancer care: issues and implications. J Clin Oncol. 2007;25(2):180-186. 5. Biosimilar and Interchangeable Products. United States Food and Drug Administration. Published October 12, 2021. Accessed September 20, 2022. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. 6. Data on file. Coherus BioSciences, Inc.; 2022 7. Data on file. Coherus BioSciences, Inc.; 2021. 8. UDENYCA^® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2021. 9. Neulasta^® (pegfilgrastim) package insert. Thousand Oaks, CA: Amgen Inc.; 2021.

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

Biosimilars create competition for change

The rising cost of treatment continues to remain at the forefront of physician and patient concerns.

Biosimilars offer choice

Biosimilars can drive down the cost of care while delivering quality treatment to those who need it. As high-value biosimilar competition continues to enter the market, providers are realizing the power of choice.

Coherus BioSciences was established in 2010 with the mission to improve patient access to high-quality biologics for life-altering diseases by leveraging the biosimilar regulatory pathway.

Benefits of biosimilars

The need for UDENYCA®

UDENYCA® offers significant costsavings for your practice6

Wholesale acquisition cost (WAC)*

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

G-CSF expanded use during COVID-19 pandemic

UPDATED RECOMMENDATIONS

For further information from each organization:

Biosimilars create
competition for change

The rising cost of treatment continues to remain
at the forefront of physician and patient concerns.

The need for UDENYCA^®

UDENYCA^® offers significant cost
savings for your practice⁶