The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab).
While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters.
An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus biosimilar makers must submit additional data to the Agency, specifically switching studies, to receive this status.
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The first product to be deemed interchangeable by the US Food and Drug Administration (FDA) was Semglee (insulin glargine) in July 2021, but this week saw the first monoclonal antibody (mAb) be granted this status in the form of Boehringer Ingelheim’s Cyltezo being interchangeable with AbbVie’s blockbuster drug Humira.
“Cyltezo is interchangeable with Humira’s original concentration, citrate-free, with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety,” a Boehringer Ingelheim spokesperson told BioProcess Insider.
“The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as interchangeable across all of these indications.”
While the approval marks a milestone for both Boehringer Ingelheim and the US regulatory framework, Cyltezo will not be available commercially until July 2023 due to a legal agreement between AbbVie and Boehringer.
In 2020, Humira clocked in sales of $16.1 billion for AbbVie in the US alone.
“While we don’t comment on our pricing or launch strategy, we believe that the introduction of biosimilars will improve the lives of patients, as well as contribute to the quality and economic sustainability of healthcare systems,” we were told.
Citizen’s Petition
Despite the approval, Boehringer Ingelheim is still lobbying the FDA to change its interpretation of how the strength of a biosimilar is determined, having filed a Citizen Petition with the Agency last year. The FDA has, to date, provided an interim response stating it is yet to have resolved the issues raised.
“We remain committed to making Cyltez commercially available as an Interchangeable biosimilar with Humira in 2023 and will continue to work with them to resolve questions posed in our Citizen Petition.
“In Boehringer Ingelheim’s view Cyltezo should be considered to have the same ‘strength’ as the corresponding original concentration and high-concentration versions of Humira because they contain the same total drug content per container (e.g., 20, 40 mg, etc., of adalimumab).”