Second Humira Biosimilar Approved in the United States

Boehringer Ingelheim Pharmaceuticals announced that the FDA has approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab), according to a press release.

Cyltezo was approved as a monotherapy or in combination with methotrexate or a non-biologic disease-modifying anti-rheumatic drug. It is administered through a pre-filled syringe.

Boehringer said they also plan to seek approval for an auto-injector of the biosimilar to expand options 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 healthcare providers and patients,” said 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 US, and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

Cyltezo was approved to treat:

· 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

· moderate to severe plaque psoriasis

The biosimilar approval was based on numerous findings from analytical, pharmacological, non-clinical and clinical development trials that showed Cyzelto is highly-similar to the reference product.

Boehringer expects that the European Medicines Agency will provide a regulatory decision for Cyzelto this year.

Due to patent litigation with AbbVie, Cyltezo is not currently commercially available, according to the release. Amgen’s Humira biosimilar, Amjevita (adalimumab-atto), is engaged in a similar lawsuit. AbbVie alleges that Amgen is infringing on 61 Humira patents, but are only including 10 in the lawsuit. Despite Amjevita’s approval in September 2016, the drug has yet to be launched in the US market.