Boehringer nabs FDA’s first interchangeability designation for its Humira competitor

Zachary Brennan

Senior Editor

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

The field’s current frontrunner is Amgen’s Amjevita (adalimumab-atto), which is likely to launch in January 2023, although others have won approvals and will hit the market later in 2023, including Sandoz’s Hyrimoz (adalimumab-adaz), Pfizer’s Abrilada (adalimumab-afzb) and Samsung’s Hadlima (adalimumab-bwwd). Others from Fresenius Kabi, Coherus, and Momenta may be coming too, pending approval.

Experts will be keen to see which competitors take the largest share of Humira’s $15B+ annual market, and how low the price drops. Five Humira biosimilars are currently marketed in Europe, and the price has declined by more than 50%, although later entrants have trouble grabbing market share, according to Bernstein biotech analyst Ronny Gal.

But unlike the US, Europe does not use an interchangeability designation, so all of the competitors can be used interchangeably with the reference product and without a doctor’s prescription. This would seem to suggest that Boehringer would have a major jump on the field, but some experts claim that Cyltezo and other Humira biosimilars are approved for a concentration of the reference product that people no longer use.

Another potential Humira competitor from Alvotech is also seeking an interchangeability designation for its biosimilar, which has yet to be FDA approved. The company is still locked in a court battle with AbbVie, but it claims to be developing the first biosimilar for the higher concentration of Humira, which is much more widely used now than when the other biosimilars first won FDA approval back in September 2016.

“So when those biosimilar companies enter in 2023, we expect that only 10% of Humira sales in the US – around 15 to 16 billion, only 10% will be [the lower concentration] 50 mg. We, on the other hand, were the first to get filing acceptance [with the FDA] of the higher concentration, so we can focus on 90% of the market when we come out,” Alvotech CEO Róbert Wessman previously told Endpoints News.