Which company makes rituximab? Unpacking the Original Maker and Biosimilars

October 8, 2025 •

3 min read

First approved by the FDA in 1997, rituximab has since revolutionized the treatment of several B-cell cancers and autoimmune diseases. The journey to market involved multiple companies, and today, an expanding list of manufacturers produce this essential medicine. So, which company makes rituximab, and what do you need to know about the different versions?

Quick Summary

The original rituximab, sold under the brand names Rituxan and MabThera, was a collaboration between IDEC Pharmaceuticals, Genentech, and Biogen, later coming under the full ownership of Roche. Following patent expiration, a competitive market for biosimilars has emerged, with many manufacturers offering their own versions.

Key Points

Original Maker: Genentech and Biogen Idec originally developed and co-marketed the innovator drug, Rituxan, in the United States.
Global Ownership: The international distribution of the originator drug, MabThera, is handled by Roche, which acquired Genentech in 2009.
US Biosimilars: In the US, several companies offer FDA-approved rituximab biosimilars, including Truxima (Celltrion/Teva), Ruxience (Pfizer), and Riabni (Amgen).
Lower Costs and Greater Access: The development of biosimilars has made rituximab more affordable, which is crucial for increasing access to this essential medicine in various healthcare systems.
Similar Efficacy: Biosimilars are proven to be highly similar to the original product in terms of safety and effectiveness, despite some brand name distinctions in approved indications.

The Originator: Rituxan and its Developers

The original version of rituximab was the result of a multi-company effort spanning over a decade of research. It is a chimeric monoclonal antibody, a type of biological drug that targets and binds to the CD20 protein on the surface of B-cells, triggering their destruction.

IDEC Pharmaceuticals: The initial development of the antibody known as IDEC-C2B8 was led by IDEC Pharmaceuticals, which later merged with Biogen in 2003. The first clinical trials began in the early 1990s.
Genentech: In 1995, IDEC partnered with Genentech to finance and accelerate the drug's development. Genentech co-marketed the drug in the United States under the brand name Rituxan.
Biogen: As a result of the merger with IDEC, Biogen became a co-marketer of Rituxan in the US alongside Genentech.
Roche: The Swiss pharmaceutical giant Roche is a major global player in rituximab's history. It had a partial stake in Genentech early on and eventually acquired full ownership in 2009. Outside the US, Roche primarily markets the originator drug under the brand name MabThera.

The Rise of Rituximab Biosimilars

Like many blockbuster biologics, rituximab's patents eventually expired, opening the market to biosimilars. Biosimilars are highly similar versions of an approved reference product, with no clinically meaningful differences in terms of safety, purity, or potency. The approval of biosimilars has increased competition, driven down costs, and improved patient access to this vital therapy globally.

Several companies have brought biosimilar versions of rituximab to market in various regions around the world. In the United States, several FDA-approved biosimilars are available.

Notable Rituximab Biosimilar Manufacturers

Celltrion and Teva: In a joint effort, these companies launched Truxima (rituximab-abbs), the first FDA-approved biosimilar for rituximab in the US. It is approved for various indications, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
Pfizer: This pharmaceutical powerhouse produces and markets Ruxience (rituximab-pvvr), another FDA-approved rituximab biosimilar, with indications covering several cancers and autoimmune diseases.
Amgen: Amgen manufactures Riabni (rituximab-arrx), which gained FDA approval for all Rituxan indications, including rheumatoid arthritis. Riabni is a key player in expanding access to this treatment.
Dr. Reddy's Laboratories and Fresenius Kabi: These companies have collaborated to bring their own biosimilar versions to market, with Dr. Reddy's announcing its intent to enter regulated markets like the US and EU. In the EU, Dr. Reddy's Ituxredi received market authorization in 2024.

Comparison of Rituximab Products

The following table provides a comparison of the original rituximab and some of the prominent biosimilar versions available in the US and other markets.


Product Name (Brand)	Manufacturer / Developer	Market (Example)	Status	Notes
Rituxan	Genentech / Biogen (US)	US	Originator	Original rituximab product.
MabThera	Roche	Global (excl. US/Japan)	Originator	Brand name for rituximab outside the US.
Truxima (rituximab-abbs)	Celltrion / Teva	US, EU, Canada	Biosimilar	First FDA-approved biosimilar for rituximab.
Ruxience (rituximab-pvvr)	Pfizer	US, EU	Biosimilar	Approved in 2019 by the FDA.
Riabni (rituximab-arrx)	Amgen	US, EU	Biosimilar	Approved for all original Rituxan indications.
Ituxredi	Dr. Reddy's Laboratories / Fresenius Kabi	EU	Biosimilar	Received market authorization in the EU in 2024.

Global Impact of Rituximab and its Manufacturing

The availability of rituximab and its biosimilars has profoundly impacted global healthcare, especially in treating cancers and autoimmune disorders. As an essential medicine, access to affordable versions is a priority for organizations like the World Health Organization (WHO), which has prequalified biosimilars to ensure quality and affordability in resource-limited settings.

The ongoing market evolution, with new biosimilars constantly being developed and approved, ensures a stable and competitive landscape. This benefits patients by reducing costs and increasing treatment options while maintaining high standards of quality and efficacy, as required by regulatory bodies like the FDA and EMA.

Conclusion: A Diverse Market of Trusted Manufacturers

In summary, while Genentech, Biogen, and Roche are the companies behind the original rituximab (Rituxan/MabThera), the market is now much broader. The entry of biosimilar manufacturers such as Celltrion/Teva (Truxima), Pfizer (Ruxience), and Amgen (Riabni) has introduced competition, leading to greater affordability and accessibility for patients. The continued innovation and competition in the market will benefit patients by ensuring that this life-saving medication remains a viable and accessible treatment option for a range of serious conditions.

Frequently Asked Questions

Rituxan is the original brand-name rituximab, initially developed by Genentech and IDEC Pharmaceuticals. Biosimilars like Truxima, Ruxience, and Riabni are highly similar, FDA-approved versions produced by different companies after the original patent expired. They have the same active ingredient and similar clinical effects, but some biosimilars may have slight differences in approved indications.

Yes. Biosimilars undergo rigorous testing and regulatory review to prove they are as safe and effective as the original product. Regulatory bodies like the FDA and EMA ensure there are no clinically meaningful differences.

The initial patents for the innovator drug Rituxan/MabThera have expired in many countries. This allows other pharmaceutical companies to produce their own biosimilar versions, leading to multiple brand names on the market and fostering competition.

Truxima (rituximab-abbs) is a rituximab biosimilar that was jointly developed and launched by Celltrion Healthcare and Teva Pharmaceutical Industries.

Ruxience (rituximab-pvvr) is a rituximab biosimilar manufactured and marketed by Pfizer.

Riabni (rituximab-arrx) is a rituximab biosimilar produced and marketed by Amgen Inc..

Yes. Roche markets the original rituximab, MabThera, outside the US. It also gained full ownership of Genentech, the US co-marketer of Rituxan, in 2009.