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

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

Tuba Khan

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

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  • 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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