Tony Hagen is senior managing editor for The Center for Biosimilars®.
Results of an analytical similarity test provide additional evidence in support of a biologics license application filed with the FDA by Amgen and Allergan.
An analytical similarity assessment has demonstrated that the Amgen and Allergan rituximab biosimilar candidate (ABP 798) is structurally and functionally similar to its reference biologic counterparts marketed in the United States and Europe.
Amgen, of Thousand Oaks, California, and Allergan, based in Dublin, Ireland, submitted a biologics license application to the FDA for review of ABP 798 in December 2019. ABP is a CD20-directed antibody that promotes cancer cell death through cytolysis, or excess fluid absorption. The reference product is indicated for treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
The analytical assessment evaluated the antigen binding properties of ABP 798 and demonstrated that ABP 798 has similar amino acid sequence; structure; glycan profile, which relates to pharmacodynamic and pharmacokinetic attributes; and biological activity. There were minor differences in biochemical attributes that were not considered clinically meaningful.
The authors of the study concluded that ABP 798 is “highly analytically similar” to the reference rituximab product (Rituxan [United States], MabThera [European Union]) and said the findings support use of ABP 798 in all approved indications of the reference product.
ABP 798 was developed to offer the same strength and dosage approved for reference rituximab in the United States and Europe: 10 mg/mL in 100-mg and 50-mg single-use vials for intravenous administration. The study evaluated active and inactive ingredients to assess safety, efficacy, and product quality of the biosimilar candidate.
Amgen developed the biosimilar and is collaborating with Allergan to develop and commercialize 4 oncology antibody biosimilars, including ABP 798. Allergan became a property of AbbVie in May 2020.
There are 2 rituximab biosimilars on the market in the United States currently: Ruxience (Pfizer) and Truxima (Celltrion/Teva).
Seo N, Huang Z, Kuhns S. Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product. Biologicals. Published online September 1, 2020. doi:10.1016/j.biologicals.2020.08.002