FDA to Review Supplemental Biologics License Application for Another Adalimumab Biosimilar

FDA accepts supplemental Biologics License Application for Hyrimoz HCF, a biosimilar with the same indications as adalimumab (Humira).

The FDA has accepted for review a supplemental Biologics License Application (sBLA) for adalimumab-adaz (Hyrimoz HCF; Sandoz), a 100 mg/mL high-concentration formulation (HCF) of the reference adalimumab (Humira).1 Hyrimoz is an inhibitor of the tumor necrosis factor (TNF) protein that is overproduced in some autoimmune conditions.2

Indications of adalimumab that are not protected by orphan exclusivity on the application include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.1

“Biosimilars play a crucial role in generating billions of dollars of savings for patients and the US health care system every year, while improving healthcare sustainability,” said Keren Haruvi, president, Sandoz Inc, in a press release.1

Hyrimoz HCF would cost significantly less than the reference medicine, Humira, while offering similarly efficacy based on the results of an early stage trial.1,2

In the phase 1 pharmacokinetics (PK) bridging study, Sandoz compared Hyrimoz 50 mg/mL with the new citrate-free Hyrimoz HCF. The product met all its primary objectives, highlighting consistent pharmokinetics, safety, and immunogenicity to the Hyrimoz 50 mg/mL.1,2

If approved by the FDA, Hyrimoz 100 mg/mL citrate-free HCF would be the first Sandoz biosimilar that is released for this disease state in the United States.1

“Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it,” Haruvi said.1

Although generic drugs are chemically identical to other drugs, biosimilars are biologic products (produced from and/or contain components of living organisms) that have a similar function to branded drugs, but contain different, unique compositions.2,3

Adalimumab is still the world’s best-selling drug since 2012, accruing more than $20 billion for Abbvie, the parent company.2

References

  1. Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF). Novartis. News Release. July 21, 2022. Accessed on July 21, 2022. https://www.novartis.com/news/media-releases/sandoz-supplemental-biologics-license-application-accepted-us-fda-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation-hcf
  2. Keown, Alex. Sandoz Takes Aim at AbbVie's Humira with FDA Acceptance of Biosimilar Application. BioSpace. Article. July 21, 2022. Accessed on July 21, 2022. https://www.biospace.com/article/sandoz-takes-another-shot-at-abbvie-s-humira-with-fda-review-of-approved-biosimilar
  3. Ogbru PharmD., Omundhome. Biologics (Biologic Drug Class). Medicine Net. Article. Accessed on July 21, 2022. https://www.medicinenet.com/biologics_biologic_drug_class/article.htm#what_is_a_biologic_drug_biologics