Vizient Submits Response to the US FDA for Draft Guidance on Biosimilars Development

9. Vizient Submits Response to the US FDA for Draft Guidance on Biosimilars Developments

Shots:

  • The company submitted report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed biosimilars and interchangeable insulin products
  • The guidance suggests recommendations as when and whether comparative clinical immunogenicity study will be needed for insulins to support the application under the US FDA
  • In May 2019, the US FDA conducted public hearing for biosimilars namely:  The Future of Insulin Biosimilars, Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products,” and is also supported by Vizient. The approval of biosimilars and interchangeable insulins will further access in decreasing health care expenses and will give multiple options for patients with diabetes  

Click here to read full press release/ article | Ref: Vizient | Image: Signbox