– Innovative design enables five-minute pegfilgrastim delivery time –
– Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving pegfilgrastim –
REDWOOD CITY, CA, USA I December 26, 2023 I Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY™, the company’s on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
“The on-body injector for UDENYCA is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” said Denny Lanfear, CEO of Coherus. “Cancer patients and their physicians will now be able to choose the UDENYCA administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”
“Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs. We expect that UDENYCA ONBODY’s five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors,” said Paul Reider, Coherus’ Chief Commercial Officer.
“Our state-of-the-art UDENYCA ONBODY device is unlike other approaches in that it is not adapted or repurposed from other medical uses,” said Rich Hameister, Coherus’ Chief Technical Officer. “This is a clean sheet, grounds-up, de novo approach designed for pegfilgrastim administration that applies proprietary technology and user insights to produce a reliable and highly intuitive patient experience.”
UDENYCA ONBODY was designed with patients in mind; key features include an indicator and status light and auditive signal that help patients confirm the dose has been administered and a strong and well-tolerated adhesive. After the dose is administered, the needle automatically retracts, which reduces the risk of needlestick injury.
The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data as well as adhesive performance and tolerability data.
Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.
About UDENYCA
UDENYCA® is the only pegfilgrastim brand approved in the United States available in three administration options—prefilled syringe (PFS), autoinjector (AI) and OBI—providing patients and healthcare providers with choice, control, and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA.
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.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use: UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Full Prescribing Information available at www.UDENYCA.com
- Neulasta prescribing information
- UDENYCA prescribing information
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with LOQTORZI in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and plans to launch LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1 inhibitor, in the U.S. in January 2024.
SOURCE: Coherus Biosciences
Post Views: 506
– Innovative design enables five-minute pegfilgrastim delivery time –
– Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving pegfilgrastim –
REDWOOD CITY, CA, USA I December 26, 2023 I Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY™, the company’s on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
“The on-body injector for UDENYCA is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” said Denny Lanfear, CEO of Coherus. “Cancer patients and their physicians will now be able to choose the UDENYCA administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”
“Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs. We expect that UDENYCA ONBODY’s five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors,” said Paul Reider, Coherus’ Chief Commercial Officer.
“Our state-of-the-art UDENYCA ONBODY device is unlike other approaches in that it is not adapted or repurposed from other medical uses,” said Rich Hameister, Coherus’ Chief Technical Officer. “This is a clean sheet, grounds-up, de novo approach designed for pegfilgrastim administration that applies proprietary technology and user insights to produce a reliable and highly intuitive patient experience.”
UDENYCA ONBODY was designed with patients in mind; key features include an indicator and status light and auditive signal that help patients confirm the dose has been administered and a strong and well-tolerated adhesive. After the dose is administered, the needle automatically retracts, which reduces the risk of needlestick injury.
The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data as well as adhesive performance and tolerability data.
Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.
About UDENYCA
UDENYCA® is the only pegfilgrastim brand approved in the United States available in three administration options—prefilled syringe (PFS), autoinjector (AI) and OBI—providing patients and healthcare providers with choice, control, and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA.
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.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use: UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Full Prescribing Information available at www.UDENYCA.com
- Neulasta prescribing information
- UDENYCA prescribing information
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with LOQTORZI in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and plans to launch LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1 inhibitor, in the U.S. in January 2024.
SOURCE: Coherus Biosciences
Post Views: 506
