Adalimumab biosimilars shaping market, research states

According to data and analytics company GlobalData, Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market.

“Of all the adalimumab biosimilars, Cyltezo is of note due to the company taking the extra and uncommon step of showing interchangeability to Humira,” highlighted Adeleke Badejo, Senior Analyst of Immunology at GlobalData.

Exclusivity in the biosimilars market

With the loss of exclusivity of AbbVie’s Humira (adalimumab), the potential revenue replacing Humira has resulted in a rapidly overcrowded market. This has developed following numerous adalimumab biosimilar offerings being brought to market. There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated.

Worldwide sales for Humira peaked at $21.2 billion in 2022, a product that was launched in 2002. Yet with the loss of exclusivity and the launch of Amgen’s Amjevita in January 2023, the first US adalimumab biosimilar, AbbVie reported a revenue decline of 26.1 percent in the first quarter compared to the same time last year.

First biosimilar to HUMIRA® available in US

“Since Amjevita, seven other agents have been introduced to the US market,” commented Badejo, who added that release of Pfizer’s Abrilada is delayed until November 2023.

To date, there are only four biosimilars that have received interchangeability status. GlobalData noted that more are expected.

Mylan’s Hulio (adalimumab), launched in Europe in 2018, is currently undergoing interchangeability studies. Boehringer gained interchangeability status with the aim to make Cyltezo distinct when compared to the abundance of these biologic medicines in this class.

Earlier this year, in May 2023, the European Commission (EC) granted a marketing authorisation for EPYSQLI™. The Soliris (eculizumab) biosimilar is indicated as a treatment for patients with the rare haematology disorder paroxysmal nocturnal haemoglobinuria (PNH).

Badejo concluded: “How Cyltezo and the other adalimumab biosimilars succeed in the coming years may determine the path for the next anticipated biosimilar offerings.”