Rituximab with the trade name Rituxan is an oncology drug that interferes with the growth and spread of cancer cells in the body. Rituxan infusion(a CD20-directed cytolytic antibody) is used to treat certain autoimmune diseases and types of cancer. This type of antibody therapy can be used alone or with chemotherapy. This drug is on the World Health Organization’s List of Essential Medicines, a list of the most important medications needed in a basic health system. Rituxan cost is around $989 for per vial. Common Rituxan side effects are headache, fever and chills.
Researcher Nabil Hanna and coworkers at IDEC Pharmaceuticals developed Rituximab under the name IDEC-C2B8.
In 1997: the U.S. Food and Drug Administration approved to treat B-cell non-Hodgkin lymphomas resistant to other chemotherapy regimens.
In 2010: The European Commission approved Rituximab for maintenance treatment after initial treatment of follicular lymphoma.
In 2014: Genentech reclassified Rituxan as a specialty drug. This class of drugs is only available through specialty distributors in the US.
In 2016: It gained EU approval in a formulation for subcutaneous injection for CLL but it is originally available for intravenous injection (e.g. over 2.5 hrs.).
In February 2013, Patents on the drug expired in Europe and also in the US in September 2016.
Rituximab was the first monoclonal antibody to be approved for therapeutic use. It is a prescription medicine used for the treatment of adult patients with
- Relapsed or refractory, Low-grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma
- Previously untreated follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma
- Non-progressing (including stable disease), Low-grade CD20-positive non-Hodgkin’s lymphoma
- Previously untreated diffuse large CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
- Microscopic Polyangiitis (MPA)
- Moderate to severe Pemphigus Vulgaris (PV) in an adult patient
- Non–Hodgkin’s Lymphoma (NHL)
Tumor cells like most normal cells have receptors on their surfaces that many kinds of chemicals, proteins, etc. can be attached to them. When it happens, they can cause changes in the cells. CD20 is a receptor present in more than 90% of B-cell non-Hodgkin’s lymphomas and molecules attach to it can affect the growth and development of the tumor cells and, sometimes, the production of new tumor cells.
A biologic product highly similar to a licensed biologic “originator” with no clinically meaningful differences in safety, purity, or potency between them is called a biosimilar. Europe’s nationalized healthcare systems have caused pressure for cost-effective therapies, so that with 27 biosimilars already approved in the EU and only nine approved in the US, Europe still leads the biosimilar race. Currently, two different rituximab biosimilar products were approved in the EU between February and July 2017. They are called Celltrion’s Truxima and Sandoz’s Rixathon. Celltrion has decided to market its product under the names Blitzima, Tuxella, and Ritemvia; this is a strategy that has been chosen to generate more total market share.
|Potential biosimilar (manufacturer)||Development details|
|ABP 798 (Amgen)||Comparative efficacy and safety clinical trials in RA and NHL (ongoing)|
|BX2336 (BioXpress Therapeutics)||In the company pipeline|
|CT-P10 (Celltrion/Hospira)||Application submitted to EMA in Nov 2015 and approved Feb 2017|
|Plant-produced rituximab biosimilar (iBio)||Rituximab produced in no transgenic plants|
|MabionCD20 (Mabion)||Comparative efficacy and safety clinical trials in NHL and RA (ongoing)|
|PF-05280586 (Pfizer)||PK study in RA (completed); comparative efficacy and safety study in follicular lymphoma (ongoing)|
|GP2013 (Sandoz)||Application submitted to EMA in May 2016|
|L01XC02 (Sandoz)||Application approved by EMA in June 2017|
|EMA (European Medicines Agency); FDA (US Food and Drug Administration); NHL (non-Hodgkin’s lymphoma); PK (pharmacokinetics); RA (rheumatoid arthritis); WHO (World Health Organization)|
Table 1: Biosimilars of Rituximab in development
Rituxan in the Global Market
In 1997, FDA approved Rituximab and in the same year, its global sales achieved 5.5 million USD. Then, the number of approved indications and global sales rose steadily. Rituximab is considered a blockbuster drug due to global sales of 7.072 billion USD in 2012. The following Figure shows the global sales of rituximab between 1997 and 2020.
Figure 1. Global sales of rituximab between 1997 and 2020. Note that figures from 2014 – 2020 are just estimation (sales data from Drug Analyst Ltd.).
Rituxan price is around $989 for per vial. It is so expensive than other traditional antirheumatic drugs, such as Methotrexate and Leflunomide; but compared with other biological treatments for rheumatoid arthritis, they have a similar price. Currently, Biogen and Genentech are the main Rituxan suppliers in the U.S. but Hoffmann–La Roche in Canada and the European Union, Chugai Pharmaceuticals, Zenyaku Kogyo in Japan and AryoGen in Iran co-marketed it. We can also consider Dano Health as big Turkish pharmaceutical wholesaler for supplying of Rituxan.