So it begins: Next Humira biosimilars launch in US

This week has seen the launch of new and lower-priced biosimilars to AbbVie’s Humira (adalimumab), many months after Amgen’s Amjevita (adalimumab-atto) was released in the US in January.

As pharmaphorum recently reported, the entrance of biosimilars to Humira is a significant event for a number of reasons, not least because the drug is the top-selling pharmaceutical product of all time. According to Statista, the product has hit more than $10 billion in annual sales every year for the last decade, earning a total of over $200 billion globally since first approval in 2002.

According to Drugs.com, the price of two subcutaneous kits of Humira can cost between $7,299 to $14,588, depending on dosage, and the biosimilars launched this first week in July aim to offer a much better deal. Indeed, a recent study by the Leonard D Shaeffer Center for Health Policy & Economics at the University of Southern California found that biosimilars promote such healthy competition and price reduction.

So it was that Saturday 1st July was a busy day. Organon and Samsung Bioepsis were first to launch biosimilar Hadlima (adalimumab-bwwd) that day, at the sale price of $1,038 per carton containing two pre-filled pens or syringes. This is, according to the two companies, an 85% discount on Humira’s list price.

Also on Saturday, Sandoz announced that its biosimilar Hyrimoz (adalimumab-adaz) was being offered under its Sandoz One Source programme, designed to provide support to patients with education, reimbursement, and affordability. Additionally, the Hyrimoz formulation is a citrate-free high concentration, aiming to cut injection volume by half and result in fewer injections in particular patients.

The first of the month also saw Boehringer Ingelheim make available Cyltezo (adaliumam-adbm), which the company’s executive director and biosimilar commercial lead, Stephen Pagnotta, noted is the “first and only FDA-approved interchangeable biosimilar to Humira.” This FDA interchangeability designation means that the biosimilar can be used in place of the branded product without need for a prescription change, as there is no increased safety risk or less efficacy.

Celltrion was next to announce the availability on Monday 3rd July of its biosimilar Yuflyma (adalimumab-aaty) at a monthly list price of $6,576.50, which comes either as an auto-injector or as a pre-filled syringe.

Indications for which Humira’s regulatory exclusivity have already lapsed include rheumatoid arthritis, Crohn’s disease, plaque psoriasis, ulcerative colitis, and hidradenitis suppurativa. And all four new biosimilars are authorised to treat the breadth of these.

Notably, in its year-end 2022 earnings summary, AbbVie posted a 22% drop in Humira’s international sales, and in the first quarter of 2023 revenues had slid by 25%.

Back in April, pharmaphorum’s editor-in-chief Jonah Comstock spoke with Goodroot’s CEO, Mike Waterbury, and Nuwae Health’s CEO, Ralph Pisano. They discussed the availability of Humira biosimilars, which, according to Goodroot’s research, is unlikely to actually lower prices very much. You can listen in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Stitcher, and Podbean.