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The US FDA approves Cyltezo (adalimumab-adbm) as the first biosimilar that is interchangeable with Humira

 Last Update: 2021-11-02
 Source: Internet
 Author: User

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Boehringer Ingelheim today announced that the US Food and Drug Administration Administration ( the FDA ) approved Cyltezo (adalimumab -adbm) supplemental Biologics License Application (sBLA), the Cyltezo as the first and Humira (adalimumab single Anti) interchangeable biosimilars
.

The FDA initially approved Cyltezo for the treatment of a variety of chronic inflammatory diseases in 2017, and the latest approval designates it as an indication that can be used for all Humira

A biosimilar is a type of biopharmaceutical whose development is highly similar to the approved reference biologics, with no clinically significant differences in safety, potency, and purity
.

Interchangeable biosimilars must first meet the FDA's high standards for biosimilars

The approval of interchangeability is supported by positive data from Boehringer Ingelheim's phase III randomized VOLTAIRE-X clinical trial, which marks the first time the FDA has approved such a study
.

The VOLTAIRE-X experiment investigated the effect of multiple switching between Humira and Cyltezo

The additional studies showed that Cyltezo with Humira equivalent, converted in pharmacokinetics between the treatment group and the continuous treatment group dynamics, function, immune immunogenicity and safety were not significantly different additional studies that show Cyltezo with Humira, etc.

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