Big Molecule Watch
June 30, 2023

CYLTEZO® to Launch on July 1 as the First Interchangeable HUMIRA® Biosimilar

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States.  Boehringer Ingelheim has also announced that with CYLTEZO’s commercial launch, pharmacy-benefit manager Optum Rx (a subsidiary of UnitedHealth Group), which currently covers more than 66 million patients, will place CYLTEZO injection as a preferred brand on its commercial formulary.  As we previously reported, the FDA first approved CYLTEZO in 2017, and in 2021 approved its supplemental Biologics License Application as the first and, at present, still only, HUMIRA® (adalimumab) biosimilar to receive interchangeable status.  Like HUMIRA, CYLTEZO is approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

In addition to CYLTEZO, the FDA has approved eight additional adalimumab biosimilars over the last six years.  At present, only one other adalimumab biosimilar, Amgen’s AMJEVITA® (adalimumab-atto), is currently available on the US market, having launched in January 2023, though it is not currently designated as interchangeable.  Various other approved adalimumab biosimilars are also expected to launch in July 2023, with several currently undergoing FDA review for interchangeability designation.

Stay tuned to Big Molecule Watch for continued updates on this topic.

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