The King is dead? Humira biosimilars begin to flood the US

AbbVie’s Humira, the top selling drug of all time, now faces multiple threats in the US with the launch of a slew of adalimumab biosimilars.

By the end of 2022, monoclonal antibody (mAb) Humira (adalimumab) had pulled in over $200 billion in sales for AbbVie (and previously Abbott) – more than any other drug. While biosimilars have tapped away at sales in Europe and outside the US for several years, the drug still pulled in $21.2 billion last year alone, mostly due to American sales.

However, 2023 has long been cited as the year Humira would face biosimilar competition in the US, after a web of AbbVie patents and legal agreements with a host of biosimilar developers had, until now, kept competition at bay.

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Following a 2017 settlement with AbbVie, Amgen managed to secure a five month window of exclusivity ahead of a hungry pack of adalimumab makers and thus launched Amjevita in February. The biosimilar was launched using a two-tier pricing system, offering discounts of 55% and 5% of Humira’s wholesale acquisition cost, or list price.

But since the beginning of July, the pack has caught up, launching several more biosimilars in the US targeting the same set of indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.

Biosimilar giant Sandoz launched its version, Hyrimoz, describing the market entry as offering “another treatment option for those who need adalimumab but might have previously been unable to access or afford this critical medicine.” It hopes to stand out from the crowd through its high-concentration formulation (HCF), which offers a 50% reduction in injection volume compared to the standard 50 mg/mL dose, and the patient-friendly Sensoready autoinjector.

Boehringer Ingelheim, meanwhile, believes its biosimilar Cyltezo has the edge due to it being the only biosimilar to Humira approved as interchangeable. This means it can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. It 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 the status.

The company is pricing Cyltezo at 5% to 7% below Humira’s list price, similar to Sandoz and to Fresenius Kabi, which is selling its biosimilar Idacio as a self-administered prefilled syringe and a self-administered pre-filled pen.

Organon and its partner Samsung Bioepis, meanwhile, have launched Hadlima, administered via the PushTouch autoinjector. Perhaps more appealing is the product, consisting of two pre-filled pens or two pre-filled syringes, which comes at a list price of $1,038, an 85% discount in comparison to Humira.

A similar discount is offered by Coherus for its biosimilar Yusimry, while Biocon – which picked up its adalimumab product through the $3.3 billion acquisition of Viatris’ biosimilars division in 2022 – is selling Hulio at discounts of 5% and 85%.

While Pfizer’s Humira biosimilar Abrilada was approved in the US back in 2019, legal wranglings with AbbVie mean the firm will not launch the biosimilar before November 20, 2023.

And finally, the arrival of Alvotech’s AVT02 has, as expected, been delayed following due to manufacturing issues at a facility in Reykjavik, Iceland. The firm announced on June 28 it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA), meaning Alvotech must resubmit a Biologics License Application (BLA) for AVT02, triggering a six-month review period and a new Biosimilar User Fee Act (BsUFA) date.