First Round of Adalimumab Biosimilar Launches in July

After years of waiting and legal battles, the first of the 8 adalimumab biosimilars expected to launch in July 2023 have entered the market: Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Coherus Biosciences’ Yusimry (adalimumab-aqvh), Organon and Samsung Bioepis' Hadlima (adalimumab-bwwd), and Sandoz' Hyrimoz (adalimumab-adaz).

The products reference Humira (adalimumab) and are each offered in autoinjector and prefilled syringe options. Cyltezo and Yusimry have low-concentration formulations, whereas Hyrimoz and Hadlima were launched with a high-concentration and low-concentration options. Cyltezo and Yusimry are also citrate-free, as well as the high-concentration versions of Hadlima and Hyrimoz, which allows for less injection site pain for patients.

Humira is used to treat several rheumatic and immune conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriasis, ulcerative colitis, Crohn’s disease, non-infectious uveitis, and hidradenitis suppurativa. Cyltezo and Hyrimoz have been approved for 8 of these indications, and Yusimry and Hadlima has been approved for 7.

The launches are the first for adalimumab biosimilars since Amgen’s Amjevita (adalimumab-aato) launched in January 2023. In addition to these products, Hulio (adalimumab-fkjp), Abrilada (adalimumab-aafzb), Abrilada (adalimumab-afzb), Idacio (adalimumab-aacf), and Yuflyma (adalimumab-aaty) will launch in July 2023.

Cyltezo and Interchangeability

Cyltezo was approved by the FDA in August 2017. It is unique because it is the only one of the 9 FDA-approved adalimumab biosimilars to have an interchangeability designation, allowing for specialty pharmacists to distribute Cyltezo instead of Humira without having to obtain permission from a physician first.

“The Crohn’s and colitis patient community welcomes adalimumab biosimilars, including Cyltezo, as new options to treat these inflammatory conditions…. We look forward to seeing how these medications may improve patient care,” commented Michael Osso, president and CEO of the Crohn’s & Colitis Foundation, in a statement from Boehringer Ingelheim.

In theory, interchangeability designations allow for patients to have better access to medications, especially in cases of drug shortages, supply chain issues, or stocking challenges. Additionally, the interchangeability label is what convinced Optum Rx, a large pharmacy benefit manager (PBM), to add Cyltezo to its preferred formulary lists at parity with Humira.

There are only 4 biosimilars in the United States with an interchangeability label: 2 insulin glargine products, 1 ranibizumab biosimilar, and Cyltezo. In addition, Organon/Samsung Bioepis, Pfizer, Celltrion USA, and Alvotech are taking steps to obtain the designation for their respective adalimumab biosimilars. However, even if they are all successful, most will likely receive the new label after initially launching in the United States.

Yusimry and Cost Plus Drugs

Yusimry was approved in December 2021. In the beginning of June 2023, Coherus Biosciences announced a partnership with the Mark Cuban Cost Plus Drug Company to bring Yusimry to patients at a lower price.

Cost Plus Drugs, an online pharmacy created by SharkTank’s Mark Cuban, aims to bring low-cost generic drugs to the public, regardless of a patient’s health coverage status. The new partnership is the first time Cost Plus Drugs will offer a biologic to its customers.

Yusimry will be offered to patients at $569.27 plus dispensing and shipping fees. The biosimilar will be available with an autoinjector presentation featuring a 29-gauge needle and will be included in the Team Cuban Card prescription benefit program, allowing for patients to obtain their prescriptions from a local independent pharmacy at the same price they would get through the online platform.

The partnership led to AbbVie, the developer of Humira, filing a preliminary injunction against Coherus, alleging that Coherus’ partnership with Cost Plus Drugs infringed on a previous agreement between AbbVie and Coherus that granted the latter a nonexclusive license to commercialize Yusimry. Since the filing, AbbVie and Coherus have agreed to settle the dispute.

Additionally, SmithRx has become the PBM to announce that it will cover Yusimry. The PBM will offer the drug at more than a 90% discount from Humira and is working with Cost Plus Drugs and Coherus to work out coverage options.

Hadlima and Hyrimoz

The low-concentration versions of Hadlima and Hyrimoz were approved in July 2019 and October 2018, respectively. The high-concentration (HCF) version of Hadlima was approved in August 2022 and Hyrimoz HCF was approved in March 2023.

According to a statement from Organon, Hadlima's "PushTouch autoinjector was specifically designed with the patient in mind, with a thin 29 [gague] needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface that is intended to fit into a patient’s lifestyle." The device was awarded the Arthritis Foundation’s Ease of Use Certification, which was granted by the Intuitive Design Applied Research Institute.

Organon also offers the "Hadlima For You" patient support program, which provides access to adalimumab education material to patients and includes a co-pay program as well as dedicated nurse coaches who can assist patients who are looking to switch from the originator to Hadlima.

Hadlima is available in a carton with 2 prefilled pens or syringes at a list price of $1038, an 85% dicount from Humira.

Sandoz has also established a patient support program for Hyrimoz, dubbed the Sandoz One Source for Hyrimoz program. The program offers patients educational, reimbursement, and affordability support. Hyrimoz' autoinjector device, the Sensoready pen, has an ergonomic deisng with a triangular shape and buttonless injection for self-administration. The device also has a 360° viewing window for visual feedback.

"This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the US. With this launch, we are entering the US immunology market and continuing to fulfill our commitment to expand access to important medicines for patients," expressed Keren Haruvi, president of Sandoz' North America division.