Riabni

Summary: Riabni^® is the third FDA-approved version of rituximab (reference product, Rituxan) manufactured by Genentech.

The product was originally designated as ABP798. Amgen submitted a biologic license application for approval via the 351(k) biosimilar pathway in December 2019. The Food and Drug Administration (FDA) approved the application on December 17, 2020.

Like the other two approved rituximab biosimilars (Truxima^® and Ruxience^®), Riabni was not approved for the reference product’s autoimmune indication (rheumatoid arthritis). Amgen did submit a clinical study for rheumatoid arthritis, in which the company stated there was no clinically meaningful difference in outcomes between their product and the reference product Rituxan^®. This drug was launched in January 2021.

Amgen, based in Thousand Oak, California, is a leading global biotechnology company. The company focuses on six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Amgen Biosimilars is the division responsible for biosimilar commercialization. Riabni is the fifth Amgen biosimilar approved by the FDA. Amgen and Allergan have worked together on four oncology products together, with two of the products being FDA approved, Kanjinti^® (trastuzumab) and Mvasi^® (bevacizumab). Other products approved include Amjevita^® (adalimumab) and Avasola^® (infliximab). Additionally, Amgen has three biosimilar products in the pipeline: aflibercept, eculizumab, and ustekinumab. Amgen also has reference products that currently face biosimilar competition (filgrastim and pegfilgrastim).

Riabni was the third and perhaps last rituximab biosimilar to be approved by the FDA, owing to other potential biosimilar candidates being derailed in recent years.  This product was launched in January 2021, and biosimilar rituximab has now captured about 50% of the marketshare for its oncology indications. Boehringer Ingelheim, Sandoz, Viatris, and Samsung Bioepis/AstraZeneca (partners in a joint venture called Archigen) have run into either business roadblocks or regulatory problems in bringing their products to market. None of these agents will likely move towards FDA application.

Riabni was approved for the non-automimmune indications only. Truxima was approved for rheumatoid arthritis and Wegener’s granulomatosis indications in December 2019, and launched these two indications in May 2020. However, it is not clear as to whether payers will exclude Ruxience coverage for the nonapproved indications.

Rituximab Biosimilar(s) Approved by the FDA

(September 29, 2021) The data emphasize one key trend: Biosimilar competition drives down the average sales price (ASP) of the category; this happens quickly for many categories, even those with modest discounts at launch.

(December 22, 2020) Amgen added another notch on its biosimilar belt last week, receiving approval from the Food and Drug Administration (FDA) to market ABP798, its biosimilar version of Rituxan^®. The drug, dubbed Riabni™ (rituximab-arrx), is the third biosimilar rituximab available in the US.

(November 20, 2020) Samsung Biologics announced in its third quarter earnings report that they and partner Astra Zeneca have agreed to shut down their joint venture Archigen Biotech. Archigen was created in 2014 with the hope of developing a biosimilar to reference product Rituxan/MabThera for the treatment of follicular lymphoma.

(May 4, 2020) Partners Teva and Celltrion announced the launch of their biosimilar Truxima for two autoimmune indications (rhematoid arthritis and Wegener’s granulomatosis).

(January 27, 2020) In December, the company launched its bevacizumab biosimilar Zirabev^®, and on January 23, Pfizer announced the availability of its rituximab biosimilar Ruxience^®. Ruxience is the second launched biosimilar to the reference product Rituxan^®.

(November 8, 2019) When Pfizer announced its intention just more than a week ago to begin marketing its rituximab biosimilar Ruxience^® in January 2020, industry watchers wondered when we might hear a response from its sole approved competitor. The wait was over quickly: Teva and Celltrion will begin shipping their own rituximab biosimilar Truxima^® on November 11.

(July 24, 2019) On July 22, 2019, the Food and Drug Administration (FDA) announced the approval of Pfizer’s Ruxience, a biosimilar of rituximab. Compared with reference agent MabThera, this biosimilar proved to produce equivalent efficacy and safety in a phase 3 trial.

(March 25, 2019) An agreement was announced between Pfizer and Roche (Genentech), which concludes litigation over a key patent for Rixutan. This may affect when Pfizer decides on marketing the product.

(January 24, 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.

(November 28, 2018) On November 28, 2018, the Food and Drug Administration (FDA) announced the approval of rituximab-abbs (Truxima™), produced by Celltrion and marketed by Teva. Approval for this rituximab biosimilar was overwhelmingly recommended by the FDA’s Oncology Drug Advisory Committee by a vote of 16-0 in October.

(October 30, 2018) Sandoz announced that it would halt its efforts to obtain approval for its biosimilar version of rituximab from the US Food and Drug Administration (FDA).

(October 8, 2018) The information package released by reviewers for the Food and Drug Administration (FDA) indicates that a positive recommendation for Celltrion’s rituximab biosimilar is likely at the Advisory Committee meeting on October 10.

(May 30, 2018) Anticipating that its issues with the Incheon, South Korea, manufacturing plant will be resolved, Celltrion has resubmitted its biologic license application for a rituximab biosimilar (CT-P10).

(May 2, 2018) Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab.

(April 5, 2018) Celltrion and its partner Teva were dealt a significant blow today, as the Korean manufacturer announced that the latest two biosimilar candidates were rejected by the Food and Drug Administration.

(July 5, 2017) Celltrion announced June 30, 2017 that it has submitted its 351(k) application to the Food and Drug Administration for approval of its biosimilar version of rituximab. This represents the first biosimilar application for rituximab, a monoclonal antibody to CD20..

(January 3, 2017) Just weeks after Celltrion presented data at the American College of Rheumatology meeting demonstrating that its product CT-P10 is as safe and effective as Rituxan^®for the treatment of rheumatoid arthritis (RA), the European Medicines Agency (EMA) received the recommendation to approve the product for use in the EU.

(September 28, 2016) The results of a phase 3 trial presented at the American College of Rheumatology meeting proved that a biosimilar version of Rituxan provided equivalent results over a 24-week study period compared with the originator product.

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