– UDENYCA® On-Body Injector (OBI) achieved both pharmacokinetic and pharmacodynamic bioequivalence in a randomized clinical trial
– Coherus plans to apply for US marketing authorization for UDENYCA® OBI in 2022
REDWOOD CITY, Calif., October 5, 2021 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (“the Company”; Nasdaq: CHRS) today announced positive results in a randomized, open, crossover study evaluating pharmacokinetic (PK) and pharmacodynamic (PD) Bioequivalence of UDENYCA® (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) compared to the currently marketed UDENYCA® pre-filled syringe (PFS). The study met all primary endpoints of PK bioequivalence as well as the key secondary pharmacodynamic endpoint, ANC (absolute neutrophil count). No new safety signals were observed. 189 subjects took part in the study, who were randomized in a 1: 1 ratio to receive one of two treatment sequences from UDENYCA®: OBI followed by PFS or vice versa, with a treatment interval of 6 to 8 weeks.
Coherus plans to file a pre-regulatory filing with the U.S. Food and Drug Administration (FDA) in 2022 to apply for marketing approval for UDENYCA® OBI and expects a standard 10-month review period. Coherus expects the commercial launch of the UDENYCA® OBI immediately after approval.
“UDENYCA® quickly became the best-selling pre-filled syringe pegfilgrastim in the US within months of its launch in 2019, establishing Coherus as a trusted partner for oncologists, and demonstrating the power of biosimilar competition to expand patient access to an important cancer drug . ”Said Denny Lanfear, CEO of Coherus. “As our OBI program progresses, we are excited about the potential to offer vendors and patients a new on-body injector presentation of UDENYCA®, if approved, and more than directly compete with Neulasta® Onpro® 50% of the share is held by the entire pegfilgrastim market. “
An FDA-cleared UDENYCA® OBI would provide vendors with a highly sought-after alternative to the original product’s on-body pegfilgrastim delivery system, eliminating the need for patients to return to a hospital or other clinical setting the day after chemotherapy UDENYCA®.
The story goes on
UDENYCA® is the number 1 prescription pegfilgrastim pre-filled syringe in the United States.
UDENYCA® is a leukocyte growth factor that reduces the incidence of infections manifested by febrile neutropenia in patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia .
Restrictions on use: UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for the transplantation of haematopoietic stem cells.
Contraindications: Patients with a history of severe allergic reactions to pegfilgrastim or filgrastim products. The reactions included anaphylaxis.
Warnings and Precautions:
Fatal rupture of the spleen: Assess patients who report pain in the upper left abdomen or shoulder due to an enlarged spleen or a ruptured spleen.
Acute Respiratory Distress Syndrome (ARDS):
Assess patients who develop a fever, pulmonary infiltrates, or shortness of breath. Quit UDENYCA® in patients with ARDS.
Serious allergic reactions, including anaphylaxis:
The majority of the reported events occurred during the first exposure. Allergic reactions, including anaphylaxis, may recur within days of discontinuing initial antiallergic treatment. Permanently discontinue UDENYCA® in patients with severe allergic reactions.
Sickle cell crises: Serious and sometimes fatal crises have occurred. Stop using UDENYCA® if you have a sickle cell crisis.
Glomerulonephritis: The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and kidney biopsy. In general, events resolved upon dose reduction or discontinuation. Evaluate and consider a dose reduction or interruption of UDENYCA® if causality is likely.
Leukocytosis: White blood cell counts of 100 x 109 / L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of the complete blood count (CBC) during UDENYCA® therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor the platelet count.
Capillary leak syndrome: Has been reported following administration of G-CSF, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. The episodes vary in frequency and severity and can be life-threatening if treatment is delayed. If symptoms develop, carefully monitor them and apply standard symptomatic treatment, which may include intensive care.
Potential for stimulatory effects of tumor growth on malignant cells: The possibility that pegfilgrastim products may act as a growth factor for any type of tumor, 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 radiation therapy in patients with breast and lung cancer. Monitor patients in these settings for signs and symptoms of MDS / AML.
Aortitis: In patients receiving pegfilgrastim products, reports have been made as early as the first week after starting therapy. The manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased markers of inflammation (e.g., c-reactive protein and white blood cell count). Consider aortitis if signs and symptoms develop with no known etiology. If aortitis is suspected, UDENYCA should be discontinued.
Nuclear Imaging: Increased bone marrow haematopoietic activity in response to growth factor therapy has been associated with transient positive changes in bone imaging. Take into account when interpreting bone imaging results.
Side effects: The most common side effects (≥ 5% difference in incidence compared to placebo) are bone pain and pain in the extremities.
To report suspected adverse reactions, please contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Complete prescribing information at www.UDENYCA.com
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company with the goal of improving access to low-cost medicines that can have a huge impact on patients’ lives and creating significant savings for the healthcare system. Coherus’ strategy is to build a leading immuno-oncology franchise, funded with cash from its commercial biosimilar business. More information is available at www.coherus.com.
Coherus is commercializing UDENYCA® (pegfilgrastim-cbqv) in the United States and expects to launch toripalimab, an anti-PD-1 antibody, and biosimilars from Lucentis®, Humira® and Avastin®, if approved, by 2023.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ plans to issue a UDENYCA Pre-Authorization Addendum in 2022 -On-body injector to be submitted; Coherus’ expected schedule for the FDA’s review period; Coherus’ ability to gain approval to showcase UDENYCA’s on-body injectors; Coherus’ Post-Approval Plans to Bring UDENYCA On-Body Injector; the ability of Coherus to successfully compete against another pegfilgrastim injector device for the body; Coherus’ ability to generate cash flow from its UDENYCA® business; the potential for Coherus to gain approval for other biosimilar products or for toripalimab in the United States; Coherus plans to invest the cash generated from its commercial biosimilar business in building a focused immuno-oncology franchise; Coherus’ ability to prepare for planned launches by 2023 of toripalimab and humira®, Avastin® and Lucentis® biosimilars, if approved.
Such forward-looking statements involve significant risks and uncertainties that could cause actual results, performance or accomplishments of Coherus to differ materially from future results, performance or accomplishments expressed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus regulatory filings; the risk that Coherus will be unable to enter into commercial transactions and other matters that may affect the availability or commercial potential of Coherus’ drug candidates; as well as the risks and uncertainties of potential patent litigation. All forward-looking statements contained in this press release speak only as of the date of their publication. Coherus assumes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, and the risks relating to Coherus ‘business in general, see Coherus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021; the Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on February 5, 2021 August, 2021 and its future periodic reports filed with the Securities and Exchange Commission. The results for the quarter ended June 30, 2021 are not necessarily indicative of our results of operations for future periods.
Coherus contact information:
Coherus BioSciences, Inc.
+1 (949) 903-4750