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FDA Approves Coherus' Novel UDENYCA ONBODY™ Delivery System for pegfilgrastim-cbqv

Coherus BioSciences, a biopharmaceutical company with a focus on developing innovative immunotherapies for cancer treatment, has received FDA approval for UDENYCA ONBODY™. This on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), a biosimilar to pegfilgrastim used post-chemotherapy, aims to reduce the occurrence of infection, specifically febrile neutropenia.

The approval marks the culmination of significant research and development investment, resulting in a unique and proprietary device for automatic medication delivery. Cancer patients and their healthcare providers now have the option to choose from various administration presentations, including a prefilled syringe, autoinjector, or the groundbreaking on-body injector. UDENYCA ONBODY™ stands out with its five-minute injection time and retractable needle mechanism, enhancing patient experience and minimizing the risk of needlestick injuries.

Designed for patient convenience, UDENYCA ONBODY™ features indicator lights, audible signals for dose confirmation, and a well-tolerated adhesive. The automatic retraction of the needle post-administration further reduces the likelihood of needlestick injuries.Indicated for decreasing infection incidence, especially febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive anti-cancer drugs, UDENYCA® comes with important safety considerations.

Physicians should assess patients for acute respiratory distress syndrome (ARDS) in case of fever, lung infiltrates, or respiratory distress, and discontinue UDENYCA® if ARDS occurs. Additionally, patients with acrylic adhesive allergies should exercise caution, as significant reactions may arise. Severe and sometimes fatal sickle cell crises have been reported, necessitating discontinuation of UDENYCA® if such crises occur.

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