The loss of exclusivity of AbbVie’s Humira (adalimumab) has become a perfect scenario to test if the Biologics Price Competition and Innovation (BPCI) act in the US can achieve the intention of the law. The potential revenue replacing Humira has resulted in many adalimumab biosimilar offerings being brought forth (currently nine FDA-approved agents), and a rapidly overcrowded market. Against this backdrop, Cyltezo from Boehringer Ingelheim has shown the intersection of price and regulation in the biosimilar market, says GlobalData.
Humira has long been a very profitable asset for AbbVie, with steadily rising annual US sales since its launch in 2002; peaking at $18.6 billion in 2022 ($21.2 billion global). However, with the loss of exclusivity, and the launch of Amgen’s Amjevita, the first US adalimumab biosimilar, in January 2023, an instant impact of the biosimilar is apparent, with AbbVie reporting a first quarter decline of 26.1% in revenue compared to the same time last year.
Adeleke Badejo, Senior Analyst – Immunology at GlobalData, comments, “Since Amjevita, seven other agents have been introduced to the US market, with only Pfizer’s Abrilada delayed untill November 2023 for its release. Of all the adalimumab biosimilars, Cyltezo is of note due to the company taking the extra and uncommon step of showing interchangeability to Humira.”
The interchangeability designation requires additional statutory safety standards to be satisfied and should be supported by data showing that the risk in terms of safety or diminished efficacy of alternating or switching between biosimilar and innovator is not greater than the risk of using the innovator without change. To date, there are only four biosimilars that have received interchangeability status, however, more are expected; Mylan’s Hulio (adalimumab) is currently undergoing interchangeability studies. Boehringer attained interchangeability with the intention of it being a point of distinction for Cyltezo from the many other biosimilars in this class.
Badejo continues, “Although a reasonable assumption, the denotation of interchangeable with Humira is not expected to have any significant effect on healthcare providers (HCPs) prescribing habits.”
GlobalData’s interviews with key opinion leaders (KOLs) reveals that specialists indicated a lack of concern in transferring patients from Humira to biosimilars in general. Providers also repeatedly iterated that they typically prescribe adalimumab with its generic name to avoid needless confrontation or disruption of therapy, which indirectly removes the merit of interchangeability, and return choice of agent to payer and pharmacy benefits managers (PBM). This shift from patient to payer also alters the influence of lower priced biosimilars on the market. This underlies the significance of the bipartisan PBM Oversight Act rising through Congress and its effect on the landscape.
Badejo concludes, “How Cyltezo and the other adalimumab biosimilars succeed in the coming years may determine the path for the next anticipated biosimilar offerings.”