Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases

October 18, 2021 Auto Bot approval, Biosimilar, Biosimilars, Boehringer Ingelheim, FDA, inflammatory diseases, regulatory, sBLA 0

Shots:

  • The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases
  • The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, and safety b/w both the groups. The results were presented at the AAD 2021 conference
  • Currently, Cyltezo is not commercially available in the US, its commercial license will begin on Jul 01, 2023. The FDA originally approved Cyltezo in 2017 to treat multiple chronic inflammatory diseases

Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Pharmaceutical Technology

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