On November 2, 2018 Coherus BioSciences, Inc. (NASDAQ: CHRS), reported that the U.S. Food and Drug Administration (FDA) has approved UDENYCA (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy (Press release, Coherus Biosciences, NOV 2, 2018, View Source [SID1234531675]). UDENYCA is Coherus’ first drug to receive FDA or EC approval.
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"We are excited to announce that Coherus has received FDA approval for UDENYCA. I want to thank the Coherus team, our strategic partners, and the U.S. Food and Drug Administration for this extraordinary achievement," said Denny Lanfear, Chairman, CEO and President of Coherus BioSciences. "The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S. We believe that competition is essential in controlling burdensome price increases, and UDENYCA will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals."
"For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch," said Chris Thompson, Senior Vice President of Sales. "Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period."
The approval of UDENYCA was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.
"UDENYCA’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects," said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. "In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of UDENYCA, but also advanced the understanding of the immunogenic response of pegfilgrastim products."
The European Commission approved UDENYCA on September 21, 2018.
The company will provide additional details with respect to pricing and launch timing on the November 8 earnings call.
About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a PEGylated growth colony-stimulating 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. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.
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.
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 UDENYCATM in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCATM in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCATM 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.