Five Adalimumab biosimilars now available in the US market

July 1 marked the launch of 5 different adalimumab (Humira) biosimilars, initiating the first round of therapeutic alternatives to market, including adalimumab-abdm (Cyltezo), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), adalimumab – adaz (Hyrimoz) and adalimumab-fkjp (Hulio). These drugs join adalimumab-atto (Amjevita), the first biosimilar of adalimumab launched on January 31, 2023.¹

Adalimumab-adbm (Cyltezo)

Adalimumab-adbm, manufactured by Boehringer Ingelheim, was first approved in 2017 for the treatment of multiple chronic inflammatory conditions, with approval as an interchangeable biosimilar followed in 2021 by the first and only FDA-approved adalimumab biosimilar. As of July 1, adalimumab-adbm is available as a pre-filled syringe or as a Cyltezo Pen autoinjector.²

The efficacy of adalimumab-adbm is supported by VOLTAIRE-X, a phase 3 randomized comparative clinical trial in which researchers evaluated multiple steps between the biosimilar and the reference product. Study results demonstrated pharmacokinetic equivalence, highly similar efficacy and immunogenicity, and comparable safety in patients who received the reference product continuously or who switched from the reference product to the biosimilar.

Biosimilars like [adalimumab-adbm] they have the potential to increase patient access to critical biologics, which can benefit people living with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis, said Steven Taylor, president of the Arthritis Foundation. We applaud the availability of yet another treatment option for physicians and patients in the United States.

Adalimumab-aqvh (Yusimry)

Coherus Biosciences’ adalimumab biosimilar adalimumab-aqvh (Yusimry) also became available on July 1, at a list price of $995 per package for two 40 mg/0.8 mL auto-injectors, a discount of more than 85 percent compared with adalimumab ($6922 for 2-pen box).³

The price of [adalimumab] is nearly $90,000 a year today, putting this important therapy out of reach for many patients who are facing difficult financial health issues, Coherus president and CEO Denny Lanfear said in a news release, adding that an equivalent prescription for adalimumab -aqvh is less than $13,000 per year.

Adalimumab-aqvh is available as a citrate-free formulation via autoinjector and 29 gauge needle. The drug was approved in 2021 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Adalimumab-bwwd (Hadlima)

Adalimumab-bwwd, manufactured by Samsung Bioepis, is another of the new biosimilars available from July 1st. Adalimumab-bwwd is available in a high-strength citrate-free formula (100 mg/mL) and a low-strength citrate-containing formula (50 mg/mL), ensuring seamless continuity of care for all patients.⁴

As the largest loss of exclusivity event in pharmaceutical history, this is a singular time for the US healthcare system to embrace biosimilars, said Organon CEO Kevin Ali.

Adalimumab-bwwd list price for one carton, including 2 pre-filled pens or pre-filled syringes, is $1038 at an 85% discount over adalimumab. The treatment is available in 24 global markets as of 2018 and has been evaluated in more than 20 real-life studies involving more than 5100 patients.

Adalimumab-adaz (Hyrimoz)

Sandozs adalimumab-adaz citrate-free is now available in a highly concentrated injection and is approved to treat all of the same indications as its reference product.⁵ The highly concentrated formulation of adalilmumab-adaz offers a 50% reduction in injection volume compared to the 50 mg/mL concentration and may reduce the number of injections required for individuals requiring at least 80 mg/0.8 mL of dosage, according to a press release. This formulation uses the same autoinjector as adalimumab-adaz 50 mg/mL: the Sensorady pen, an ergonomic triangular-shaped device with push-button injection.

Adalimumab-fkjp (Hulio)

Following availability in Europe and Canada, Biocon Biologics adalimumab-fkjp is now available to patients in the United States. To ensure broad access to patients, the manufacturer is offering 2 options to pharmacy health plans and benefit managers: Hulio is available at a list price 5% below the current price of adalimumab and adalimumab-fkjp is available at a list price approximately 85% below the current price of adalimumab.⁶

Biocon Biologics is pleased to deliver [adalimumab-fkjp], a patient-friendly 2-click prefilled pen available in the U.S. for patients with select inflammatory diseases, said Mathew Erick, chief commercial officer at Advanced Markets. There are no buttons to press. Patients remove the cap and push the device against the skin to trigger the injection.

Stay tuned Drug topics for the latest updates on biosimilars.

References

1. Amjevita (adalimumab-act), first biosimilar of Humira, now available in the US. Press release. Amgen. Jan 31, 2023. Accessed July 5, 2023. https://www.amgen.com/newsroom/press-releases/2023/01/amjevita-adalimumabatto-first-biosimilar-to-humira-now-available-in-the-stati United

2. Cyltezo, the first and only FDA-approved interchangeable biosimilar of Humira, now commercially available in the US news release. Boehringer Ingelheim. July 1, 2023. Accessed July 5, 2023. https://www.prnewswire.com/news-releases/cyltezo-first-and-only-fda-approved-interchangeable-biosimilar-to-humira-now-commercially-available -negli -united-states-301868465.html

3. Coherus launches Yusimry, a biosimilar of Humira, at $995 per carton in the US. Press release. Coherus biosciences. July 3, 2023. Accessed July 5, 2023. https://www.globenewswire.com/news-release/2023/07/03/2698528/0/en/Coherus-Launches-YUSIMRY-a-Bosimilar-of-Humira -at -995-per-Carton-in-US.html

4. Organon and Samsung Bioepis Announce US Launch of Biosimilar Humira Hadlima (adalimumab-bwwd) in Multiple Originator Consistent Presentations. Press release. Samsung Biooepis Co. July 1, 2023. Accessed July 5, 2023. https://www.businesswire.com/news/home/20230701798272/en/REPEATOrganon-Samsung-Bioepis-Announce-US-Launch-of-HUMIRA-Biosimilar -HADLIMA %E2%84%A2-adalimumab-bwwd-in-multiple-presentations-consistent-with-originator

5. Sandoz to launch high-strength formulation of Hyrimoz (adalimumab-adaz), marking Sandoz’s entry into the US immunology space. Press release. Novartis. July 1, 2023. Accessed July 5, 2023. https://www.novartis.com/news/media-releases/sandoz-launch-hyrimoz-adalimumab-adaz-high-concentration-formulation-marking-sandoz-entrance-us -immunology -space

6. After five years of successful international experience, Biocon Biologics Hulio biosimilar of Humira, now available in the United States. Press release. Biocon Biologics. July 1, 2023. Accessed July 5, 2023. https://www.biocon.com/after-five-years-of-successful-experience-internationally-biocon-biologics-hulio-biosimilar-to-humira-now-available-in United States/