WHO Clears Celltrion Rituximab for Use

In an attempt to bring biosimilars to more people, especially those in lower income countries, the World Health Organization (WHO) has certified, or “prequalified,” its second biosimilar for the treatment of cancer.

The WHO gave the nod to a rituximab biosimilar (Truxima) produced by Celltrion. The WHO prequalification program provides for full assessment of clinical and other data related to the development of biosimilars or an abbreviated pathway for prequalification that is based upon prior acceptance by a “stringent” regulatory authority, such as the FDA.

The prequalification of the Celltrion biosimilar marks the second such action since the WHO’s pilot biosimilar program was launched in 2017.

In November 2019, the WHO prequalified Samsung Bioepis’ breast cancer trastuzumab biosimilar Ontruzant, which references Herceptin.

The WHO pilot program for cancer biosimilars is aimed in particular at trastuzumab and rituximab products, and the agency has invited other manufacturers of these agents to apply for prequalification through the dual pathway program.

These agents can cost in the tens of thousands of dollars annually for oncology treatment, and so the discounts offered for biosimilars can make a huge difference for patient access, the WHO maintains.

“As with all biologic medicines, the complex development and manufacturing process for rituximab have meant high treatment costs. Therefore, access to affordable versions of this effective essential medicine in nations with fewer resources and less advanced infrastructure remains limited,” the WHO said in a statement.

Rituximab is used in the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. The WHO noted it has “significantly improved therapeutic responses and remains a fundamental component of treatment regimens” for the treatment of cancer.

In the United States, Truxima was launched in November 2019 at a 10% discount to the rituximab biosimilar, which is marketed as Rituxan in the United States and MabThera in the European Union.

In 2017, the Celltrion version of rituximab became the first biosimilar for the treatment of oncology to be approved in the European Union.

It is regulator-approved in both the United States and the European Union for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with poly-angiitis, and microscopic polyangiitis.

The WHO also offers prequalification for numerous other medicines. “Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement,” the WHO said in a release.

Rituximab is a monoclonal antibody (mAb) that binds to CD20 on the surface of B-cells, and subsequently mediates the destruction of cancer cells. Trastuzumab is a mAb that is specifically used to treat HER2-positive breast cancer, a particularly aggressive form of cancer that is often successfully treated with trastuzumab.