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Coherus Announces U.S. Launch of UDENYCA® Autoinjector

Tuesday, May 23, 2023

Coherus BioSciences, Inc. , today announced that the single-dose (6mg/0.6mL), prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv) is now available for commercial sale in the United States. UDENYCA® is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.1 UDENYCA® AI’s streamlined design offers a simple option for in-office and at-home settings of care that administers pegfilgrastim in less than 10 seconds.

“Those independent patients, with families and busy lifestyles, or those who just have a hard time coming back to the office the day after chemotherapy—that’s who is really going to benefit from the introduction of the UDENYCA® autoinjector,” said Francis Arena, M.D., Medical Director, NYU Langone Arena Oncology. "This gives us more choice in meeting our patients’ needs, and the simple administration gives confidence in at-home administration.”

“Patients have indicated in market research that quick administration, ease of use, and a sense of control and independence were the features and benefits of the autoinjector most important in their decision-making when choosing an at-home administration option. With UDENYCA AI, providers now have a new option that offers their patients where and how to receive their therapy, and health plans have a new option to increase access for patients,” said Paul Reider, Chief Commercial Officer of Coherus. “Our goal is to be the only pegfilgrastim product offering value across three differentiated presentations, fully meeting market needs and creating a durable franchise positioned to maximize market share growth. UDENYCA® AI represents substantial progress in that direction, and UDENYCA® will become the only pegfilgrastim product with three presentation options with the launch of our proprietary on-body injector later this year, if approved.”

“Innovating to address patient needs is core to our mission, and we believe UDENYCA® AI has the potential to ease the journey for patients battling cancer,” said Denny Lanfear, Chief Executive Officer of Coherus.

UDENYCA® AI has user-friendly features that promote successful delivery. The approval of UDENYCA® AI was supported by a comprehensive analytical data package, as well as a clinical study demonstrating the pharmacokinetic, pharmacodynamic bioequivalence and a comparable safety profile (including immunogenicity) of UDENYCA administered with the AI versus the prefilled syringe.

UDENYCA® AI is available through existing full-line and specialty distributors and will be priced at parity to the UDENYCA® prefilled syringe at a list price of $4,175.00 which represents a 35% discount4 from the list price of the reference product. Billing under the medical benefit for UDENYCA® AI is streamlined as it has the same permanent, product-specific Q-Code as the prefilled syringe, Q5111, and a unique NDC number of 70114-0120-01. UDENYCA Solutions™ offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance and office support to ensure successful access and reimbursement.



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