Manufacturing.

Manufacturing value.

Manufacturing
value.

UDENYCA^® is manufactured in the United States using state-of-the-art technology. The manufacturing sites are compliant with current Good Manufacturing Practice (cGMP) standards and have satisfied FDA inspection requirements.

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The facility¹

The US manufacturing facility was purposefully designed to produce PEGylated filgrastim and has successfully completed FDA inspections.

UDENYCA^® is manufactured using a continuous process. Manufacturing of UDENYCA^® has demonstrated a high level of consistency across multiple production campaigns.

The process¹

The product¹

Through robust stability studies, the FDA has approved a 36-month shelf life for UDENYCA^®, reflecting excellent product quality.

Reference: 1. Data on file. Coherus BioSciences, Inc.; 2020.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

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: Permanently discontinue UDENYCA^® in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA^® if causality is likely.

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.

INDICATION

UDENYCA^® 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.

Please see Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

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: Permanently discontinue UDENYCA^® in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA^® if causality is likely.

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.

INDICATION

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

Please see Full Prescribing Information.

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

INDICATION

INDICATION

Manufacturing.

Manufacturing value.

Manufacturingvalue.

The facility1

The process1

The product1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

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.

INDICATION

Please see Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

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.

INDICATION

Please see Full Prescribing Information.

G-CSF expanded use during COVID-19 pandemic

UPDATED RECOMMENDATIONS

For further information from each organization:

Manufacturing
value.

The facility¹

The process¹

The product¹