Boehringer Ingelheim biosimilar Cyltezo OK’d by FDA

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Drug represents second biosimilar of AbbVie's Humira

RIDGEFIELD, Conn. —  Boehringer Ingelheim Pharmaceuticals Inc. has gained Food and Drug Administration approval for Cyltezo, a biosimilar of Humira from AbbVie Inc.

Boehringer Ingelheim said Tuesday that Cyltezo (adalimumab-adbm) comes in a prefilled syringe and is indicated to treat a range of chronic inflammatory diseases, including moderate to severe active rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis (an arthritis that affects the spine), moderate to severe active adult Crohn’s disease, moderate to severe active ulcerative colitis and moderate to severe plaque psoriasis.

Currently, Cyltezo isn’t commercially available, as Boehringer Ingelheim remains in patent litigation with AbbVie. Boehringer Ingelheim said it also plans to seek approval for an auto-injector of Cyltezo as another delivery option for patients.

“Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to health care providers and patients,” stated Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

Cyltezo marks the second FDA-cleared biosimilar for Humira, the other being Amgen’s Amjevita (adalimumab-atto), which was approved last September.

Overall, the FDA has approved six biosimilars, with the other four being Samsung Bioepis’ Renflexis (infliximab-abda) and Pfizer/Celltrion’s Inflectra (infliximab-dyyb) — two biosimilars of Johnson & Johnson’s Remicade — and Sandoz’s Erelzi (etanercept-szzs), a biosimilar of Amgen’s Enbrel, and Zarxio (filgrastim-sndz), a Sandoz biosimilar of Amgen’s Neupogen. Zarxio was the first FDA-cleared biosimilar.


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