Amgen and Allergan Announce Positive Top-Line Results from JASMINE Study Demonstrating Clinical Equivalence of ABP 798 to Rituxan in CD20-Positive B-Cell Non-Hodgkin Lymphoma

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On August 22 local time, Amgen and Allergan announced positive top-line results from the JASMINE comparative efficacy study (NCT02747043) of ABP798, a rituximab biosimilar.

This was a randomized, double-blind, comparative study evaluating the efficacy, safety, and immunogenicity of ABP798 versus Roche’s Rituxan in patients with CD20-positive B-cell non-Hodgkin lymphoma. A total of 256 adult patients were enrolled and randomized into two groups to receive either ABP798 or Rituxan at a dose of 375 mg/m², administered as a weekly intravenous (IV) infusion for four weeks, followed by doses at Week 12 and Week 20. The primary endpoint was the risk difference in overall response rate.

The results showed that the study met its primary endpoint: at Week 28 of treatment, the difference in overall response rate between the ABP798 group and the Rituxan group was within the prespecified margins, demonstrating clinical equivalence in efficacy. In the study, the safety and immunogenicity of ABP798 were comparable to those of Rituxan.

The JASMINE study is the second study designed to support the regulatory submission of ABP798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met its primary endpoint of pharmacokinetic similarity. This study demonstrated clinical equivalence within the prespecified efficacy margins, as well as comparable safety and immunogenicity.

ABP798 is a monoclonal antibody with the same amino acid sequence as Rituxan and is currently being developed as a biosimilar to Rituxan. Amgen’s portfolio currently comprises 10 biosimilars, three of which have been approved in the United States: Amjevita (adalimumab), Mvasi (bevacizumab), and Kanjinti (trastuzumab).

Avastin, Herceptin, and Rituxan are Roche’s three flagship biologics. In 2018, each generated sales nearing CHF 7 billion, making them among the best-selling drugs globally. According to the U.S. FDA’s biosimilar database, a total of 23 biosimilars have been approved to date, nine of which target Roche’s three flagship products. Among these, Mvasi and Kanjinti were launched in the U.S. market in mid-July this year, becoming the first biosimilars of Avastin and Herceptin, respectively, to enter that market.

Table 1 FDA-Approved Biosimilars to Date

As the wave of biosimilars approaches, sales performance of Herceptin and Avastin is expected to suffer significant setbacks, while Rituxan may become the next target.

Despite the impact of biosimilars on Roche’s three major cash-cow brands, analysts point out that the multiple new products launched by Roche are expected to offset the losses, and the company remains capable of sustaining growth.

Reference Source:

1、Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan® (Rituximab)

2、FDA-Approved Biosimilar Products

3. Herceptin and Avastin Biosimilars Enter the US Market: Are Roche’s Good Days Here?