Boehringer’s Humira biosimilar wins US green light

US regulators have approved Boehringer Ingelheim’s Cyltezo, a biosimilar to AbbVie’s Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases.

The drug is the firm’s first biosimilar to be approved by the US Food and Drug Administration, which is allowing its use to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

Humira (adalimumab), an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. Biosimilar versions are expected to be significantly cheaper, and thus have the potential to generate substantial savings for healthcare providers.

"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," noted van Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer.

However, Cyltezo (adalimumab) will not be commercially available in the US until the group’s ongoing patent litigation with AbbVie is resolved.

AbbVie reportedly holds more than 100 patents on Humira, the world’s number one selling drug, and believes that Boehringer may infringe 74 of these with the launch of its biosimilar. It has also sued Amgen to block the launch of its proposed Humira biosimilar.