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Withdrawal of Applications for the EU Marketing Authorisation of Rituximab Mabion

It was developed as a biosimilar medicine
28 Apr 2020
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 27 March 2020, the European Medicines Agency (EMA) informed that Mabion Spolka Akcyjna withdrew its duplicate applications for marketing authorisation of Rituximab Mabion for the treatment of certain haematological malignancies and inflammatory conditions. The company withdrew the applications on 16 March 2020.

Rituximab Mabion was developed as a medicine for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia (CLL), severe rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Rituximab Mabion is a biological medicine and contains the active substance rituximab; it was to be available for intravenous infusion.

Rituximab Mabion was developed as a biosimilar medicine. This means that Rituximab Mabion was intended to be highly similar to another biological medicine already authorised in the EU (the reference medicine). The reference medicine for Rituximab Mabion is MabThera.

The active substance in Rituximab Mabion, rituximab, is a monoclonal antibody designed to recognise and attach to CD20 present on the surface of B-lymphocytes. When rituximab attaches to CD20, it causes the death of B-lymphocytes, which helps in lymphoma and CLL where B lymphocytes have become cancerous and in rheumatoid arthritis where B-lymphocytes are involved in joint inflammation. In inflammatory conditions of the blood vessels, destroying the B-lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

Laboratory studies compared Rituximab Mabion with MabThera to show if the active substance in Rituximab Mabion was highly similar to that in MabThera in terms of structure, purity and biological activity. Studies were also conducted to check that giving Rituximab Mabion produced similar levels of the active substance in the body to giving MabThera.

A main study involving 629 patients with rheumatoid arthritis compared the effectiveness of Rituximab Mabion with that of MabThera. The main measure of effectiveness was the proportion of patients whose condition improved by at least 20% after 24 weeks of treatment.

The applications were withdrawn after the EMA had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Rituximab Mabion could not have been authorised for the requested indications.

The Agency was concerned that biosimilarity between Rituximab Mabion and the reference medicine MabThera had not been established. The Agency also had concerns about the manufacturing process and the system for ensuring reliable quality of the medicine.

At the time of the withdrawal, the Agency’s opinion was that the company had not fully addressed its concerns and therefore the benefit of Rituximab Mabion could not be established.

In its letter notifying the Agency of the withdrawal of the applications, the company stated that the applications pertained only to the initial scale of manufacturing process and the applicant will prepare a new application.

The company informed the Agency that there are no consequences for patients in clinical trials using Rituximab Mabion.

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