FDA Approves sBLA for Adalimumab-adaz as Interchangeable Biosimilar for Humira


A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.

The FDA has approved a supplemental biologics license application for Sandoz’s adalimumab-adaz (Hyrimoz), in the 10 mg/0.1 mL, 20 mg/0.2 mL, and 80 mg/0.8 mL strengths, as interchangeable for all indications for adalimumab (Humira; AbbVie) that are not covered by orphan drug exclusivity, according to a press release. A provisional determination was also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar for the reference product.1

biosimilar word or concept represented by wooden letter tiles on a wooden table with glasses and a book | Image Credit: lexiconimages - stock.adobe.com

Image Credit: lexiconimages - stock.adobe.com

“This is a significant milestone in broadening access to this important medicine for the millions of patients living with chronic inflammatory disease in the [United States]. While an interchangeability designation does not mean a better safety and efficacy profile nor a higher quality standard, we recognize it is valued by some stakeholders who are critical to helping [adalimumab-adaz] reach the patients who need–and may benefit–from it,” Keren Haruvi, president of Sandoz North America, said in the press release.1

The FDA determined that the data submitted met the requirements for interchangeability. The company expects the FDA to grant interchangeability designation for the 40 mg/0.4 mL product when exclusivity expires.1

In 2018, adalimumab-adaz was approved by the FDA as a biosimilar to Humira, with indications including the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adults Crohn disease, ulcerative colitis, and plaque psoriasis. The approval was based on data from the ADMYYRA trial, showing that the biosimilar matched the reference product in safety, efficacy, and immunogenicity, for patients with moderate-to-severe RA at 24 weeks in 353 individuals. The mean change from baseline at 12 weeks in Disease Activity Score was –2.16 for the biosimilar and -2.18 for the reference product.2

In 2023, the FDA approved a citrate-free high-concentration formulation in March and launched a the biosimilar in July. Both products covered the 7 indications adalimumab was approved for, with the citrate-free formulation also approved for hidradenitis suppurativa. The high-concentration formulation was approved based on a pharmacokinetic bridging study, which met all primary objectives, including comparable pharmacokinetics and demonstrating similar safety and immunogenicity as the reference product.3,4

With the addition of Sandoz’s approval, there are 3 other biosimilars approved with an interchangeability status for Humira: adalimumab-ryvk (Simlandi; Alvotech, Teva), adalimumab-afzb (Abrilada; Pfizer), and adalimumab-adbm (Cyltezo; Boehringer Ingelheim.5

Adalimumab-atto (Amjevita; Amgen) was the first biosimilar of Humira to become approved and commercially available in the United States. It is approved for all indications, excluding hidradenitis suppurativa.6

Although only 4 interchangeable biosimilars have been approved, many other biosimilars for Humira have been approved, which has caused confusion around the interchangeability designation. This has the potential to impact the uptake and decrease patient access to the biosimilar medication, according to an article from Pharmacy Times.7

  1. Select strengths of Sandoz immunology biosimilar granted interchangeability by FDA. News release. Sandoz. May 8, 2023. Accessed May 10, 2024. https://www.us.sandoz.com/select-strengths-sandoz-immunology-biosimilar-granted-interchangeability-fda/
  2. Pharmacy Times. FDA Approves Sandoz’s Biosimilar Adalimumab. November 1, 2018. Accessed May 10, 2024. https://www.pharmacytimes.com/view/fda-approves-sandozs-biosimilar-adalimumab
  3. Antrim A. FDA Approves Adalimumab-adaz High Concentration Formulation Biosimilar. Pharmacy Times. March 21, 2023. Accessed May 10, 2024. https://www.pharmacytimes.com/view/fda-approves-adalimumab-adaz-high-concentration-formulation-biosimilar
  4. Gallagher A. Sandoz Launches Citrate-Free Adalimumab-adaz as Biosimilar for Humira. Pharmacy Times. July 5, 2023. Accessed May 10, 2024. https://www.pharmacytimes.com/view/sandoz-launches-citrate-free-adalimumab-adaz-as-biosimilar-for-humira
  5. Pharmacy Times. First Humira Biosimilar Launces in the United States. February 1, 2023. Accessed May 10, 2024. https://www.pharmacytimes.com/view/first-humira-biosimilar-launches-in-the-united-states
  6. Wehrwein P. FDA: Simlandi Becomes Third Interchangeable Humira Biosimilar After Approval. Drug Topics. February 26, 2024. Accessed May 10, 2024. https://www.drugtopics.com/view/fda-simlandi-becomes-third-interchangeable-humira-biosimilar-after-approval
  7. Park J, Woollett G. Confusion Persists Around the Interchangeability Designation for Biosimilars. Pharmacy Times. November 17, 2023. Accessed May 10, 2024. https://www.pharmacytimes.com/view/confusion-persists-around-the-interchangeability-designation-for-biosimilars
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