Boehringer’s Cyltezo, The Only Interchangeable Humira Biosimilar, Gets A New Form
Subcutaneous Form Has Been FDA-Approved Since 2017; Interchangeable Since 2021
Boehringer Ingelheim has welcomed a new FDA approval for its Cyltezo (adalimumab-adbm) interchangeable biosimilar, ahead of planned launch on 1 July.
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FDA approval for Alvotech and Teva’s AVT02 adalimumab biosimilar has once again failed to materialize as the agency issued another CRL over the product. The setback means the firms will miss their projected launch date of 1 July and will not be part of the pack launching multiple Humira rivals in the coming weeks.
As the clock ticks on the second wave of biosimilar Humira launches in the US, Sandoz and Boehringer Ingelheim have scooped much-coveted preferred listings on the commercial formulary of a major PBM for their biosimilars, following Amgen’s placement earlier this year.
Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.