Boehringer Ingelheim has secured approval from the US Food and Drug Administration (FDA) for its new autoinjector, the Cyltezo Pen.
The new autoinjector can be used to administer Cyltezo (adalimumab-adbm), which was approved by the FDA as an interchangeable biosimilar to its reference product Humira (adalimumab) in October 2021.
Cyltezo, which was initially approved as a pre-filled syringe, is intended for the treatment of multiple chronic inflammatory diseases.
Starting from 1 July 2023, the 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options.
Boehringer Ingelheim biosimilar commercial lead and executive director Stephen Pagnotta said: “The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector.
“We’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on 1 July.”
The pen’s design is centred around the patient and incorporates a one-button system for activation in just three steps. It ensures complete visibility of the drug, while the needle is securely protected.
The Cyltezo Pen is certified by the Arthritis Foundation for its ease of use.
This month, Boehringer Ingelheim joined forces with Healthy.io to roll out an at-home testing programme, Minuteful Kidney, for patients at risk of chronic kidney disease (CKD).
Healthy.io’s Minuteful Kidney is claimed to be the first and only FDA-approved smartphone-based at-home ACR test for previously untested patients.