FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved

Interchanging adalimumab-adbm was shown to be equivalent to adalimumab (Humira), with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity or safety between the switching and continuous treatment groups. Evaluated were the percentage of patients with a 75% reduction in Psoriasis Area and Severity Index (PASI75) response at week 32, anti-drug antibodies, neutralizing antibodies, minimum and maximum observed concentrations during the dosing interval, physician global assessment and patients with drug-related adverse events.

These results were presented at the American Academy of Dermatology 2021 virtual conference, April 23–25. Similar results supporting interchangeability were also reported in the VOLTAIRE-PSO study (NCT02850965).⁶

Studies from outside the U.S. have shown that other adalimumab biosimilars are also interchangeable with the reference product. These adalimumab biosimilar switching studies have been performed in patients with moderate to severe active RA and JIA. In these studies, adalimumab biosimilars demonstrated no differences in effectiveness, pharmacokinetics, immunogenicity and safety from the reference product.^7-9

Adalimumab-adbm is not yet commercially available in the U.S. The commercial license will begin on July 1, 2023.

New Combination Oral Analgesic

On Oct. 15, the FDA approved a new combination, prescription analgesic that contains a unique co-crystal formulation of celecoxib and tramadol. This formulation provides another option for multi-modal pain management. The product, called Seglentis, will contain 56 mg of celecoxib and 44 mg of tramadol in an oral tablet. A risk evaluation and mitigation strategy (REMS) will be used to encourage the treatment’s safe and appropriate use. It will be available in early 2022.¹⁰

References

1. News release: U.S. FDA approves Cyltezo (adalimumab-adbm) as first interchangeable biosimilar with Humira. Boehringer Ingelheim. 2021 Oct 15.
2. FDA approval letter: Cyltezo (adalimumab-adbm). 2017 Aug 25.
3. FDA-approved biosimilar products. U.S. Food & Drug Administration. 2021 Sep 9.
4. State biosimilar substitution laws. Mintz, Levin, Cohn, Ferris, Glovsky & Popeo PC. 2019 Feb 8.
5. News release: VOLTAIRE-X phase 3 data in patients with moderate to severe chronic plaque psoriasis support interchangeability application. Boehringer Ingelheim. 2021 Apr 23.
6. Menter A, Arenberger P, Balser S, et al. Similar efficacy, safety and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate to severe chronic plaque psoriasis: Results from the randomized phase 3 VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021 Jan;21(1):87–96. Epub 2020 Dec 29.
7. Gall S, Kiltz U, Kobylinski T, et al. No major differences between patients with chronic inflammatory rheumatic disease who underwent mono- or multiswitching of biosimilars in routine care (perception study). Ann Rheum Dis. 2021;80(suppl 1):376.
8. Horneff G, Dressler F, M. Rühlmann M, et al. Experience with adalimumab biosimilar use in clinical practice: data from the German BIKER-registry. Ann Rheum Dis. 2021;80:933–934.
9. Furst D, Keystone E, Kay J et al. Efficacy and safety after transition from reference adalimumab to CT-P17 (adalimumab biosimilar: 100 mg/mL) in comparison with the maintained treatment (CT-P17 or reference adalimumab) in patients with moderate to severe active rheumatoid arthritis: 1-year result. Ann Rheum Dis. 2021;80:1123–1124.
10. News release: Esteve Pharmaceuticals receives FDA approval for Seglentis (celecoxib and tramadol hydrochloride). Kowa Pharmaceuticals America Inc. 2021 Oct 18.