Rituxan (Rituximab) Biosimilars – 2018 Drug Pipeline Review

Rituxan (Rituximab) is utilized as one of the treatment options for rheumatoid arthritis (RA), Non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and Wegner’s Granulomatosis (WG).

In 2016 Rituxan had over $4 billion in sales in the United States, making it a lucrative area for the development of biosimilars.  As of the publication of this article, Rituxan has two biosimilars awaiting FDA review in 2018 and one product in study (see Executive Summary Table below).  All the biosimilars currently being developed have focused their studies on RA and NHL, which represents the primary usage of rituximab in practice and the more highly prevalent conditions for which Rituxan is approved.

Based on the available data it can be assumed that the FDA will approve the biosimilars for use with RA and NHL, but not for CLL and WG.  Both Truxima® and Rixathon® have interchangeability data with Rituxan specifically within the treatment for rheumatoid arthritis.  It is unknown whether this data is part of the FDA submission for these products in 2018, but if they are in the review, it can be expected that these products may be one of the first products to be listed as interchangeable.  Since these are one of the first products that could be potentially reviewed for interchangeability it will be of interest to see if the FDA will generalize this to the drug or just within the RA indication.

For our complete review of Rituxan (Rituximab) Biosimilars:



Executive Summary of Evaluation for Rituximab Pipeline:

Rituximab Biosimilar
RegulatoryStatusMarketedSubmitted for ApprovalNot SubmittedSubmitted for Approval
IndicationsNon-Hodgkins Lymphoma (NHL)ApprovedSubmitted for ApprovalIn StudySubmitted for Approval
Rheumatoid Arthritis (RA)ApprovedSubmitted for ApprovalIn StudySubmitted for Approval
Chronic Lymphocytic Leukemia (CLL)Approved
Wegner’s GranulomatosisApproved
InterchangeableNon-Hodgkins Lymphoma (NHL)
Rheumatoid Arthritis (RA)Has supporting dataHas supporting data
Chronic Lymphocytic Leukemia (CLL)
Wegner’s Granulomatosis
EfficacyNon-Hodgkins Lymphoma (NHL)Similar to RituxanNo ResultsSimilar to Rituxan
Rheumatoid Arthritis (RA)Similar to RituxanNo ResultsSimilar to Rituxan
Chronic Lymphocytic Leukemia (CLL)Not StudiedNot StudiedNot Studied
Wegner’s GranulomatosisNot StudiedNot StudiedNot Studied
Forecasted Sales
(in millions)

Source: Pharma Intelligence Center
2018$3,716No Forecast$145$16
Pipeline Updates:

April 5, 2018 – Celltrion announced the FDA issued a complete response letter (CRL) for their rituximab
biosimilar requesting additional information.  While these actions may delay the FDA approval date, the manufacturer still anticipates approval in 2018.
November 28, 2018 – the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL)

May 1, 2018 – Sandoz, a Novartis division, announced that the FDA has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.
Reference: Global Data
November 5, 2018 – Novartis, announced their intent not to pursue re-submission of the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab instead choosing to focus efforts on other biosimilar opportunities.
Reference: PharmaTimes