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Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab
The primary objective of the study was PK similarity comparing ABP 798 to rituximab. The PK endpoints of the study were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax), both of which were within the pre-specified equivalence margin. The pre-specified equivalence in efficacy endpoint was measured by Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) change from baseline at week 24. Overall, safety and immunogenicity of ABP 798 were comparable to rituximab. This is the first of two studies intended to form the basis for global regulatory submissions for ABP 798. The second study is being conducted in patients with non-Hodgkin's lymphoma.
"Results from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab, further demonstrating
ABP 798 is being developed as a biosimilar candidate to rituximab, a CD20-directed cytolytic antibody that is approved in many regions for the treatment of adult patients with moderate-to-severe rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
About the Study Design
The above referenced Phase 1/ Phase 3 study was a randomized, double-blind trial (study number NCT02792699) that evaluated the PK, efficacy and safety of ABP 798 compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. There were 311 patients enrolled and randomized (1:1:1) to receive either ABP 798, rituximab sourced from the U.S., or rituximab sourced from the EU, administered as an intravenous (IV) infusion at baseline and again at week 24. Among them, 104 patients were randomized to the ABP 798 group, 103 patients were randomized to the rituximab (U.S.) group and 104 patients were randomized to the rituximab (EU) group. The primary PK endpoints of the study were AUC and Cmax. The pre-specified equivalence in efficacy endpoint was measured by DAS28-CRP change from baseline at week 24, and the overall study duration was 48 weeks. Additionally, the study included a single transition for subjects on rituximab (U.S.) to ABP 798.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that affects approximately one percent of the adult population worldwide.1 RA can cause pain, stiffness, swelling and limitations in the motion and function of multiple joints.2 In RA, joint damage can significantly worsen over time, especially if left untreated and may impair function.3
About ABP 798
ABP 798 is being developed as a biosimilar candidate to rituximab, a CD20-directed cytolytic antibody that is approved in the U.S., EU and other regions for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a CD20-directed cytolytic antibody that has the same amino acid sequence as rituximab. ABP 798 also has the same pharmaceutical dosage form and strength as rituximab.
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Forward Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed, and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in
- Gibofsky A. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J Manag Care. 2012;18:S295-S302.
Arthritis Foundation. Rheumatoid arthritis symptoms. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/symptoms.php. Accessed June 6, 2018. Arthritis Foundation. Joint deformities in rheumatoid arthritis. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/articles/ra-deformities.php. Accessed June 6, 2018.
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