Amgen and Allergen Submit Biologic License Application to U.S. FDA for ABP 798, Biosimilar Candidate to Rituxan® (rituximab)

Amgen and Allergen Submit Biologic License Application to U.S. FDA for ABP 798, Biosimilar Candidate to Rituxan® (rituximab)

Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab), which has been approved for hematologic and autoimmune indications. The application is based on analytical, pharmacokinetic, and clinical data, along with pharmacology and toxicology data from 2 clinical trials, results of which showed that there were no clinically meaningful differences between ABP 798 and reference rituximab.

Topline results of the phase III JASMINE trial which directly compared ABP 798 with standard rituximab, were announced in August 2019. In the double-blind, comparative study, the efficacy, safety, and immunogenicity of ABP 798 was compared with rituximab in 256 adult patients with non-Hodgkin lymphoma. Patients received either ABP 798 or rituximab intravenously at 375 mg/m2 once weekly for 4 weeks, followed by dosing at weeks 12 and 20. The primary endpoint was an assessment of objective response rate (ORR) at week 28. Results showed that the ORR at week 28 was within the prespecified margin for ABP 798 compared with rituximab. Additionally, safety and immunogenicity data with ABP 798 were similar to the reference product.

Positive top-line results from a Phase 1/ Phase 3 study evaluating ABP 798 versus rituximab in patients with moderate to severe rheumatoid arthritis were reported in January of 2019. The results demonstrate that the study met its primary endpoint of pharmacokinetic (PK) similarity. Additionally, equivalent efficacy was established and a similar safety profile was demonstrated.

Earlier data showed that ABP 798 was similar to reference rituximab sourced from the European Union and the United States in relation to biological activity across a number of assays. Such tests evaluated the major and minor mechanisms of action across the approved rituximab indications. Data showed that the dose response profiles and relative activity for antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity were similar.

About ABP 798
ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal antibody that has been approved in many regions for the treatment of, among other things, adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.