Summary: Ruxience is the second FDA-approved biosimilar version of rituximab (reference product, Rituxan) manufactured by Genentech.
Originally designated PF-05280586, Pfizer submitted a biologic license application for approval via the 351(k) biosimilar pathway in September 2018. The Food and Drug Administration (FDA) approved the application on July 23, 2019 (without recommendation from the FDA’s Oncology Drug Advisory Committee.
Like the first biosimilar approved for rituximab, Teva and Celltrion’s Truxima, Ruxience was not approved for the reference product’s main autoimmune indication (rheumatoid arthritis). However, Pfizer did complete clinical trials in the use of PF-05280586 in rheumatoid arthritis. This drug is not yet marketed; a launch date has not been announced.
About the Manufacturer
Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. In addition to Ruxience, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; Trazimera, a biosimilar trastuzumab; Retacrit, a biosimilar epoetin that was approved in May 2018; Zirabev, a biosimilar bevacizumab that was approved in June 2019; and Nevistym, a biosimilar version of filgrastim that is also marketed. Pfizer’s biosimilar pipeline consists of a biosimilar adalimumab in phase 3 trials and a biosimilar pegfilgrastim in phase 1 development.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Truxima was the first rituximab biosimilar to be approved by the FDA. This product has not yet entered the marketplace. Pfizer received approval for its agent Ruxience in July 2019; launch plans for this product is not yet announced. Boehringer Ingelheim and Sandoz both had biosimilars of rituximab in Phase III development but made business decisions to not move forward with the products.
Although these two biosimilars were approved for the non-autoimmune indications of the reference product Rituxan, it is not clear as to whether payers will exclude coverage for the nonapproved uses. However, Amgen/Allergan’s investigational biosimilar also has undergone clinical testing for rheumatoid arthritis as well as non-Hodgkins lymphoma.
Rituximab Biosimilar(s) in Development
|Company Name||Product Name||Brand Name||Stage of Development|
Phase III trial completed in June 2019 for NHL
Phase III trial for rheumatoid arthritis was completed in October 2018
Met with FDA in July 2018 to finalize “ the most optimal pathway towards registering” in the US; Filed for EMA approval in June 2018
The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
(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.
Pfizer Signs Patent Settlement With Roche on Rituximab Biosimilar
(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.
Amgen and Allergan Announce Top-Line Results of Phase 1/3 Rituximab Biosimilar Trial
(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.
Rituximab Biosimilar Approved by FDA for Cancer Treatment
(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.
Sandoz Decides Against Marketing Rituximab Biosimilar in US
(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).
Celltrion's Rituximab Biosimilar Earns Positive FDA Review
(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.
Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
(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).
FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
(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.
Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
(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.
Biosimilar Rituximab Under FDA Review
(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..
Celltrion’s Rituximab Recommended for Approval in Europe
(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.
CT-P10 Rituximab Biosimilar Phase 3 Clinical Trial Results Announced
(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.