-Udenica® On-Body Injector (OBI) achieved bioequivalence in pharmacokinetics and pharmacodynamics in randomized clinical trials
-Coherus plans to seek US marketing authorization for this product Udenica®OBI in 2022
Redwood City, California, October 5, 2021 (Global News Service) – Coherus BioSciences, Inc. (the “Company”; NASDAQ: CHRS) today announced a random, Open label, cross-study positive results (PK of UDENYCA) and pharmacodynamics (PD) bioequivalence® (pegfilgrastim-cbqv) Compared with the UDENYCA currently on the market, it is administered via a proprietary OBI device® Pre-filled syringe (PFS). The study met all PK bioequivalence primary endpoints and key secondary pharmacodynamic endpoints for ANC (absolute neutrophil count). No new safety signals were observed.The study recruited 189 subjects who were randomized to receive one of UDENYCA’s two treatment sequences at a 1:1 ratio®: PFS after OBI, or vice versa, treatment interval is 6 to 8 weeks.
Coherus plans to submit a supplementary application for pre-approval to the U.S. Food and Drug Administration (FDA) in 2022 to seek marketing authorization for UDENYCA® OBI also expects a standard 10-month review period. Coherus anticipates the commercial release of UDENYCA® OBI directly issues approval.
“Udineika® Within a few months of its launch in 2019, it quickly became the best-selling prefilled syringe pegfilgrastim in the United States, making Coherus a trusted partner for oncologists and demonstrating the power of biosimilar competition to expand patient access to important cancers Opportunities for drugs,” said Denny Lanfear, CEO of Coherus. “As our OBI program progresses, we are delighted that it is possible to provide providers and patients with UDENYCA’s new body syringe demonstration®, If approved and directly compete with Neulasta® Onpro®, It retains more than 50% of the entire pegfilgrastim market. “
FDA approved UDENYCA® OBI will provide providers with an ideal alternative to replace the original polyethylene glycol filgrastim delivery system and eliminate the need for patients to return to the hospital or other clinical environment to receive UDENYCA on the second day after chemotherapy. need®.
Udenica® It is the number one pre-filled syringe of polyethylene glycol filgrastim in the United States.
Udenica® It is a leukocyte growth factor used to reduce the incidence of infections, such as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs, and clinically significant febrile diseases The incidence of neutropenia is related.
Restrictions on use: UDENYCA® It is not suitable for mobilizing peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Contraindications: Patients with a history of severe allergic reactions to polyethylene glycol filgrastim products or filgrastim products. Reactions include allergic reactions.
Warnings and precautions:
Fatal rupture of the spleen: Assess whether a patient with pain in the upper left abdomen or shoulder has an enlarged or ruptured spleen.
Acute Respiratory Distress Syndrome (ARDS):
Assess patients with fever, pulmonary infiltration, or respiratory distress. Terminate UDENYCA® In patients with ARDS.
Severe allergic reactions, including allergic reactions:
Most reported incidents occurred at the time of initial contact. Allergic reactions, including allergic reactions, can recur within a few days after the initial anti-allergic treatment is stopped. Disable UDENYCA permanently® Patients with severe allergic reactions.
Sickle cell crisis: There have been serious and sometimes fatal crises. Terminate UDENYCA® If a sickle cell crisis occurs.
glomerulus nephritis: The diagnosis is based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and kidney biopsy. Usually, the event is resolved after the dose is reduced or the drug is discontinued.Evaluate and consider dose reduction or interruption of UDENYCA® If there is a causal relationship.
Leukocytosis: White blood cell (WBC) count is 100 x 109A/L or higher was observed in patients receiving polyethylene glycol filgrastim products. Monitor complete blood count (CBC) during UDENYCA® Recommended treatment.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving polyethylene glycol filgrastim. Monitor platelet count.
Capillary leak syndrome: It has been reported that after administration of G-CSF, products including polyethylene glycol filgrastim are characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. The frequency and severity of attacks vary, and if treatment is delayed, it may be life-threatening. If symptoms occur, monitor closely and give standard symptomatic treatment, which may require intensive care.
Potential for stimulating tumor growth of malignant cells: The possibility of pegfilgrastim products as growth factors for any tumor type cannot be ruled out, including myeloid malignancies and myelodysplasia, and pegfilgrastim products are not approved for the treatment of diseases.
Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in breast cancer and lung cancer patients: MDS and AML are related to the use of pegylated filgrastim in combination with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aorticitis: It has been reported in patients receiving polyethylene glycol filgrastim products, the earliest occurrence in the first week after the start of treatment. Manifestations may include general signs and symptoms, such as fever, abdominal pain, malaise, back pain, and increased inflammation markers (such as c-reactive protein and white blood cell count). When symptoms and signs appear and the cause is unknown, aortitis should be considered. If aortitis is suspected, discontinue UDENYCA.
Nuclear imaging: Increased bone marrow hematopoietic activity in response to growth factor treatment is associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
Adverse reactions: The most common adverse reactions (incidence difference ≥5% compared with placebo) are bone pain and limb pain.
To report a suspicious adverse reaction, please call 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 prescription information is available on www.UDENYCA.com
About Coherus Biological Sciences
Coherus is a commercial-stage biopharmaceutical company whose mission is to increase the availability of cost-effective medicines that have a major impact on patients’ lives and save significant amounts of money for the healthcare system. Coherus’ strategy is to establish a leading immuno-oncology franchise, funded by cash generated from its commercial biosimilar business. For more information, please visit www.coherus.com.
Coherus sells UDENYCA® (pegfilgrastim-cbqv) In the United States, toripalimab, an anti-PD-1 antibody, and a biosimilar of Lucentis are expected to be launched by 2023®, Xiu Mei Le®, And Avastin®, If approved.
Udenica® Is a trademark of Coherus BioSciences, Inc.
Avastin® Lucitis® Is a registered trademark of Genentech.
Xiu Mei Le® Is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters described 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 for 2022 Submission of pre-approved supplements for UDENYCA systemic syringes; Coherus’ expected timetable for the FDA review period; Coherus’ ability to obtain UDENYCA body-type syringes to demonstrate approval; Coherus plans to launch UDENYCA systemic syringes after approval; Coherus succeeded with another pegfilgrastim systemic injection device Ability to compete; Coherus’ ability to generate cash flow from its UDENYCA® Commercial; Coherus has the potential to obtain approval for other biosimilar products or toripalimab in the United States; Coherus plans to invest the cash generated from its biosimilar commercial business to establish a franchise focused on immuno-oncology; Coherus is toripalimab and Humira biosimilars Ability to prepare for the projected release by 2023®, Avastin® Lucentis®, If approved.
Such forward-looking statements involve significant risks and uncertainties, which may cause Coherus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements. Such risks and uncertainties include the inherent risks and uncertainties in the clinical drug development process; the risks and uncertainties in the regulatory approval process, including the time for Coherus’ regulatory filing; the risks of Coherus’ inability to complete commercial transactions and other risks that may affect Coherus The availability or commercial potential of drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release are issued only on the date they are made. Coherus assumes no obligation to update or revise any forward-looking statements. For further explanation of the risks and uncertainties that may cause actual results to differ from those expressed in these forward-looking statements, as well as the overall risks associated with Coherus’ business, please refer to Coherus Form 10-K Annual Report as of December 31, 2020 The quarterly report on Form 10-Q for the three months and six months ended June 30, 2021 was filed with the Securities and Exchange Commission on August 5, Periodic reports to be submitted to the US Securities and Exchange Commission in 2021 and in the future. The quarterly results as of June 30, 2021 do not necessarily represent our operating results for any period in the future.
Coherus contact information:
Coherus Biosciences Corporation
+1 (949) 903-4750