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A pivotal Clinical Study of Insulin Aspart Biosimilar

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Trial Profile

A pivotal Clinical Study of Insulin Aspart Biosimilar

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 11 Jan 2023

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At a glance

  • Drugs Insulin aspart (Primary)
  • Indications Diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Sponsors Lannett

Most Recent Events

  • 04 Jan 2023 According to a Lannett media release, if successful, the company anticipate filing the Biologics License Application (BLA) the end of calendar year 2024 and potentially launching the product in calendar year 2025.
  • 04 Jan 2023 According to a Lannett media release, the company expect to file an Investigational New Drug (IND) application this Summer. The company expect to initiate this study by Fall 2023 and completing the pivotal trial in the Summer of 2024.
  • 04 Jan 2023 According to a Lannett media release, the data from animal study will be submitted to the FDA as part of the company's request, expected in the first half of calendar 2023, for a Biosimilar Biological Product Development (BPD) Type II meeting.

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