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Coherus Resubmits BLA for Udenyca OnBody for FDA Review
Issues related to finding from an FDA inspection at a third-party filler have been resolved.
Coherus BioSciences resubmitted to the FDA the supplemental biologics license application (BLA) Udenyca OnBody, the companys on-body injector of Udenyca (pegfilgrastim-cbqv).
Last month the FDA had issued a complete response letter due to an ongoing review of inspection findings at a third-party filler. Coherus officials said the issues have been resolved, and regulators had no issues related to clinical efficacy or safety, trial design, labeling, or device design or manufacturing.
“Coherus appreciates the great collaboration with our third-party manufacturer and the swift and comprehensive actions taken to address the inspectional issues raised by the agency. We are all focused on bringing this excellent product to patients as quickly as possible,” Rich Hameister, chief technical officer at Coherus, said in a press release.
Related: FDA Issues Complete Response for Udenyca OnBody
Udenyca, a biosimilar of Amgen’s Neulasta, is used prevent infection after the use of chemotherapy for patients with nonmyeloid malignancies. Udenyca is currently approved with two product offerings: a prefilled syringe and autoinjector. Both products have a list price of $4,175, which Coherus BioScience says represents a 35% discount off Neulasta. Coherus BioSciences offers a copay program for $0 for up to an annual maximum of $15,000.
The auto injection version of Udenyca was approved in March 2023 and launched in May. The original version of Udenyca was approved in November 2018 and launched on the U.S. market in January 2019. It is one of six FDA-approved biosimilars referencing Neulasta.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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