Five Adalimumab Biosimilars Now Available in US Market

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

Adalimumab-adbm (Cyltezo)

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

Adalimumab-adbm efficacy is supported by VOLTAIRE-X, a phase 3, randomized, comparative clinical trial in which researchers evaluated multiple switches between the biosimilar and reference product. Study results demonstrated pharmacokinetic equivalnce, “highly similar” efficacy and immunogenicity, and comparable safety in patients who either received the reference product continuously or who switched between the reference product and the biosimilar.

“Biosimilars such as [adalimumab-adbm] have the potential to increase patient access to critical biologic medicines, which may 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 another treatment option for doctors and patients in the US.”

Adalimumab-aqvh (Yusimry)

Coherus Biosciences’ adalimumab biosimilar adalimumab-aqvh (Yusimry) also became available on July 1, at a list price of $995 per carton for two 40 mg/0.8 mL autoinjectors—a discount of more than 85% compared with adalimumab ($6922 per carton of 2 pens).³

“The price of [adalimumab] is nearly $90,000 a year today, putting this important therapy out of reach for many patients who are experiencing difficult financial health challenges,” said Coherus’ chairman and CEO Denny Lanfear in a press 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 as of July 1. Adalimumab-bwwd is available in a citrate-free high concentration formula (100 mg/mL) and a citrate-containing low concentration 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 moment for the US health care system to embrace biosimilars,” said Kevin Ali, Organon CEO.

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

Adalimumab-adaz (Hyrimoz)

Sandoz’s citrate-free adalimumab-adaz is now available in a high concentration injection and is approved to treat all of the same indications as its reference product.⁵ The adalilmumab-adaz high concentration formulaa “offers a 50% reduction in injection volume” compared with the 50 mg/mL concentration, and “can decrease the number of injections required for people who need at least 80 mg/0.8 mL dosing,” according to a press release. This formulation uses the same autoinjector as adalimumab-adaz 50 mg/mL: the Sensoready pen, an ergonomic, triangular-shaped device with buttonless 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 patient access, the manufacturer is offering 2 options to health plans and pharmacy benefit managers: Hulio is available at a list price of 5% below current adalimumab price, and adalimumab-fkjp is available at a list price of approximately 85% below the current adalimumab price.⁶

“Biocon Biologics is pleased to make [adalimumab-fkjp], a patient friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases,” said Mathew Erick, Chief Commercial Officer of Advanced Markets. “There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection.”

Stay tuned to Drug Topics for the latest biosimilar updates.

References

1. Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States. News release. Amgen. January 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-united-states

2. Cyltezo, first and only FDA-approved interchangeable biosimilar to Humira, now commercially available in the U.S. 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-in-the-us-301868465.html

3. Coherus launches Yusimry, a biosimilar of Humira, at $995 per carton in US. News 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-Biosimilar-of-Humira-at-995-per-Carton-in-U-S.html

4. Organon & Samsung Bioepis announce US launch of Humira biosimilar Hadlima (adalimumab-bwwd) in multiple presentations consistent with originator. News 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 Hyrimoz (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space. News 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 experience internationally, Biocon Biologics’ Hulio biosimilar to Humira, now available in the United States. News 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-the-united-states/