The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.
Coherus Biosciences has announced that the FDA has approved its on-body injector version of Udenyca (pegfilgrastim-cbqv) as biosimilar to Neulasta Onpro (pegfilgrastim with 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 5-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.
Neulasta Onpro is the pegfilgrastim product that has obtained a majority market share for the pegfilgrastim sector, preventing meaningful uptake, and subsequent savings for pegfilgrastim biosimilars. Patients receiving Udenyca Onbody can have their pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
The news came several months after the FDA approved the autoinjector version of Udenyca in March 2023.
"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.”
The approval was also granted after Coherus received a complete response letter (CRL) in September 2023, which Coherus assured did not raise any issues with the on-body product’s safety or efficacy, saying that the CRL was issued because of an ongoing review at a third-party manufacturing site.
Reference
Coherus announces FDA approval of Udenyca Onbody, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv. News release. Coherus Biosciences. December 26, 2023. Accessed January 15, 2024. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-fda-approval-udenyca-onbodytm-novel-and
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.