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United States. Securities and Exchange Commission

Coherus BioSciences Receives FDA Approval for UDENYCA ONBODYtm On-Body Injector Presentation

Strategic Insights

— 1 min read

Coherus BioSciences, Inc. announced the U.S. Food and Drug Administration's approval of UDENYCA ONBODYtm, a pegfilgrastim biosimilar administered via an on-body injector (OBI) to reduce the incidence of infection as manifested by febrile neutropenia. The approval was supported by comprehensive analytical and clinical data, including pharmacokinetic and pharmacodynamic bioequivalence data. Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.

Key Takeaways:

  • Coherus BioSciences received FDA approval for UDENYCA ONBODYtm, an on-body injector (OBI) presentation of UDENYCA(r) (pegfilgrastim-cbqv), a pegfilgrastim biosimilar.
  • The approval was granted based on a comprehensive analytical and clinical data package, including pharmacokinetic and pharmacodynamic bioequivalence data.
  • The on-body injector features an indicator and status light, an auditive signal, and a strong and well-tolerated adhesive to confirm proper dose administration and reduce the risk of needlestick injury.
  • The OBI automatically retracts the needle after dose administration, minimizing the risk of needlestick injury.
  • Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024.
  • Dennis M. Lanfear, President and Chief Executive Officer of Coherus BioSciences, expressed confidence in the approval, stating, "We are pleased to have received FDA approval for UDENYCA ONBODY, which will provide patients with an alternative option for managing febrile neutropenia."
  • The approval marks a significant milestone for Coherus BioSciences in its efforts to bring UDENYCA ONBODY to market via an OBI presentation, which will enhance patient experiences and outcomes.
  • The company plans to continue advancing its pipeline of biosimilars and continue to innovate in the development of new treatments for patients with cancer and other serious diseases.

Statistics:

  • The OBI device is expected to provide a strong and well-tolerated adhesive, reducing the risk of skin irritation and improving patient comfort.
  • The comprehensive analytical and clinical data package included pharmacokinetic and pharmacodynamic bioequivalence data, demonstrating the safety and efficacy of UDENYCA ONBODY in reducing the incidence of infection as manifested by febrile neutropenia.
  • The OBI features an indicator and status light, an auditive signal, and automatic retraction of the needle after dose administration, minimizing the risk of needlestick injury.

Sources:

  • Coherus BioSciences, Inc. (2023, December 26). FORM 8-K (Current Report). UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
  • Coherus BioSciences, Inc. (2023, November 6). Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2023.

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