FDA Approves Adalimumab-Adaz High-Concentration Formulation

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As the year of adalimumab (Humira; AbbVie) biosimilars continues, the US Food and Drug Administration (FDA) recently approved a citrate-free high-concentration (HCF) formulation of adalimumab-adaz (Hyrimoz; Sandoz & Novartis).¹ Sandoz, a division of Novartis, plans to launch adalimumab-adaz HCF on July 1, 2023.

Adalimumab-adaz was originally approved by the FDA in October 2018 and was the 3rd FDA-approved adalimumab biosimilar. Adalimumab-adaz HCF has been highly anticipated, as the citrate-free version made reduce injection site pain.

Adalimumab-adaz HCF may become the 2nd available adalimumab biosimilar in the US in 2023, as it is following closely behind adalimumab-atto (Amjevita; Amgen) launched in US markets earlier this year.

The citrate-free adalimumab-adaz is approved to treat 7 indications originally treated by adalimumab, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

The FDA’s approval was based on a phase 1 pharmokinetics (PK) bridging study comparing adalimumab 50mg/mL to 100mg/mL of adalimumab-adaz HCF. All primary endpoints were met in the study, and adalimumab-adaz HCF showed compared PK and similar safety and immunogenicity as adalimumab.

Adalimumab-adaz HCF will be the first launch of a Sandoz biosimilar in the US market for the 7 specific disease dates.

Similar to adalimumab-atto, adalimumab-adaz HCF is not indicated for the treatment of hidradenitis suppurativa (HS). Adalimumab still stands as the only FDA-approved treatment for HS.

Dermatologists are closely monitoring the eventual launch of adalimumab-adbm (Cyltezo; Boehringer Ingelheim) and adalimumab-afzb (Abrilada; Pfizer). Adalimumab-adbm was granted interchangeability with adalimumab by the FDA, giving it the possibility to become the first adalimumab biosimilar available to treat HS. Pfizer has applied for interchangeability status for its adalimumab-afzb. Both biosimilars are expected to launch by July 1, 2023.²

In a previous interview, Christopher Bunick, MD, PhD, physician-scientist and associate professor of dermatology at the Yale School of Medicine, noted “It is important to understand that biosimilars are not an exact replica of the branded medicine. And so, some patients may do well or better with the branded medicine and others may do very well with the biosimilar. They're not exact copies of each other, but they're, again, similar. I think that over the coming weeks to months, it's going to be very interesting to see how [biosimilars] perform in the real-world experience with our psoriatic patients.”

References

1. Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation. Novartis. Published March 21, 2023. Accessed March 21, 2023. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation#:~:text=Basel%2C%20March%2021%2C%202023%20%E2%80%93,(adalimumab-adaz)%20injection.
2. Billingsley A. Is there a biosimilar for Humira? Yes, here are 8 Humira biosimilars launching in 2023. GoodRx Health. Updated January 3, 2023. Accessed March 21, 2023. https://www.goodrx.com/humira/biosimilars