Boehringer Ingelheim has secured approval for the Cyltezo Pen from the US Food and Drug Administration (FDA) as a new autoinjector option for Cyltezo (adalimumab-adbm).
Cyltezo is an interchangeable biosimilar to AbbVie’s Humira (adalimumab). It has been approved by the FDA for the treatment of multiple chronic inflammatory diseases.
The US health regulator had approved it initially as a pre-filled syringe.
Boehringer Ingelheim will commercially launch the 40 mg/0.8 mL pre-filled Cyltezo Pen in options of two-, four- and six-packs on 1 July 2023.
Boehringer Ingelheim executive director and biosimilar commercial lead 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 July 1.”
The pen is said to have a patient-centered design and comes with a one-button, three-step activation. It provides 100% visibility of the drug and comes with a protected needle, said Boehringer Ingelheim.
According to the Germany-based pharmaceutical company, the Cyltezo Pen has been certified as an “Ease of Use” product by The Arthritis Foundation.
Cyltezo injection is indicated for subcutaneous use to reduce signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. It is also approved for the treatment of moderately to severely active Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
