Biosimilars boosted by FDA's landmark ruling for Boehringer’s Cyltezo

The approval by the US Food and Drug Administration (FDA) of Boehringer Ingelheim's Cyltezo as an interchangeable biosimilar for Humira in certain inflammatory diseases looks set to make an already crowded field even more competitive.

The key difference with this approval is that an interchangeable biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. This can happen at the pharmacy in US states that permit pharmacy-level substitution.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said acting FDA Commissioner Janet Woodcock. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”

The FDA approval covers adult patients with forms of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

The Humira market is worth more than $15bn annually and, in addition to Boehringer's Cyltezo (adalimumab-adbm), other biosimilars that are set to launch in 2023 include Amgen’s Amjevita (adalimumab-atto), Sandoz’s Hyrimoz (adalimumab-adaz), Pfizer’s Abrilada (adalimumab-afzb) and Samsung’s Hadlima (adalimumab-bwwd).

The 2023 timeline is the result of intense legal wrangling with Humira’s maker AbbVie that ended with a 2019 agreement to delay the launches of adalimumab biosimilars. One potential disruptor to this carefully laid plan is Alvotech, which has not settled its dispute with AbbVie and has also completed a successful switching study.

In Europe, four adalimumab biosimilars have launched since 2018, with nearly 35% of European patients switched from Humira to a biosimilar by the end of 2019, despite AbbVie reducing its price for the drug.

The approval of Cyltezo is significant in the highly lucrative US market, says Bernstein analyst Ronny Gal, who called it a “landmark achievement” and pointed to the fact that it is the first interchangeable designation for a monoclonal antibody. “This will facilitate future approvals for other drugs, and we wonder if, in the long run, interchangeable biosimilars will be the only biosimilars” for such antibody therapies, he said.

To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.