new biosimilar medicine of rituximab


It is a new biosimilar of rituximab, a medicine intended for the treatment of oncohematological and rheumatic diseases.

The National Administration of Medicines, Food and Medical Technology (ANMAT) recently approved the use of the rituximab biosimilar, from the Sandoz laboratory, a division of the Novartis Group. Among other indications, it is intended for the treatment of different types of lymphoma and rheumatoid arthritis.

Approval was given thanks to the entirety of the scientific evidence presented, which supports its biosimilarity with respect to the reference medicine. The development of the biosimilar included numerous clinical studies -including the confirmatory phase III ASSIST-FL trial- that involved the participation of more than 1000 patients around the world, strengthening the robustness of the analytical evidence and demonstrating biosimilarity with the reference biological .

This made possible, among other approvals of rigorous regulatory authorities, that Sandoz’s rituximab was approved by the European Medicines Agency (EMA).

“It represents very good news for patients and for the medical staff, since we have a rituximab biosimilar backed by solid clinical research, with all the therapeutic benefits of the reference biological. It is expected that this will contribute to generating significant savings in our health system, detailed the Dr. Marta Zerga, Hematologist, Director of the Medical Area of ​​the Ángel Roffo Institute of Oncology.

New biosimilar of rituximab for the treatment of oncohematological and rheumatic diseases

What are biosimilars

Biosimilars are drugs developed from the expiration of the patent of the reference biological, approved by regulatory authorities only if they have demonstrated in rigorous pre-clinical and clinical studies to achieve the same levels of safety and efficacy as the reference biological. These are options that allow access to the same treatment at a considerably lower cost, achieving that more patients can receive this therapy and thus contributing to the sustainability of the system.

Among other clinical studies, safety and efficacy of Sandoz’s rituximab is endorsed by ASSIST-FL, a confirmatory phase III study, carried out to demonstrate the biosimilitude of the medicine with the reference biological. This multicenter, randomized, controlled, double-blind study included 629 patients with previously untreated follicular lymphoma. In the results, the pharmacology, efficacy and safety profile were found to be comparable with that of reference rituximab.

Another study called ASSIST-RT, in patients with rheumatoid arthritis, showed that interchangeability is safe, that is, that therapeutic results are not altered for the replacement in a patient of the administration of the reference biological by the Sandoz biosimilar.

“Without a doubt, the introduction of a biosimilar in a segment where there is only one competitor induces price reduction, contributes to the sustainability of the system and helps more people to access state-of-the-art therapies, “said the Lic. Natalia Jorgensen, economist specialized in Health, President of the Center for Health Technology Assessment of the ISALUD University (CETSA).

“Improve the cost-effectiveness equation of medicines facilitates the inclusion of these in the vademecums of social and prepaid works, since a lower price increases the value in health for money invested and reduces the impact on budgets, “he insisted Jorgensen.

The group of non-Hodgkin lymphomas represents the most frequent oncohematological pathology, calculating an incidence of 5 to 7 cases per 100,000 inhabitants. They are observed in both men and women and can appear at any age, although they predominate in adults. Is about lymphoid tissue tumors, usually affecting the lymph nodes, the spleen and the bone marrow. They can be asymptomatic or associated with certain symptoms, such as painless enlargement lymph node, unexplained weight loss, fatigue, night sweats, cough, or shortness of breath.

“There are multiple subtypes of non-Hogdkin lymphomas, of heterogeneous behavior. Some entities may have a very indolent evolution and may not even require treatment, while others show aggressive clinical behavior. 85% of non-Hodgkin lymphomas correspond to entities derived from B lymphocytes, in which rituximab is an essential part of the treatment, “stressed the Dra. Marta Zerga.

What are biosimilar medicines?

What are biosimilar medicines?

The treating doctor will evaluate the best treatment to follow based on the individual situation of each patient and the stage of your illness. The approved alternatives are radiotherapy, chemotherapy, monoclonal antibodies, such as rituximab, and regimens without chemotherapy among other alternatives.6.

Today, oncology in general faces difficulties in accessing innovation. The Economic load It is growing as a result of increased cancer incidence, lower mortality, longer survival, and better disease prevention, diagnosis, and treatment. This means that in many countries access to effective treatment is restricted and doctors cannot provide the best possible therapy for patients..

The biological drugs, which in the last decades have been protagonists in the approach of different pathologies like many autoimmune diseases, are complex to develop and replicate.

The approval of this Rituximab biosimilar is backed by the track record and robustness of Sandoz, which has many years of experience in this field. As a Novartis division, it has the endorsement and infrastructure of the group in development and manufacture of biosimilars, maintaining maximum quality standards and the ability to carry out a production process from start to finish. It is also a pioneer and leader in the development of biosimilars7 that passed rigorous regulatory agency standards and was the first company to receive biosimilar approval in Europe in 2006 and in the United States in 2015..

“From Sandoz, we have the objective of providing patients quality therapeutic solutions, with a long-term commitment to the care of patients with cancer and chronic inflammatory diseases with a focus on the sustainability of health systems. With our biosimilar of rituximab, we have already made this a reality in different countries of the world and we are very excited about the arrival of our medicine in Argentina, “said the Dr. Nicolás Costa, Sandoz Medical Director.

Haydée González, president of the Asociación Civil Linfomas Argentina (ACLA), expressed that “in our institution, which for 15 years we have supported lymphoma patients, we work day by day so that people who have lymphoma have advice and support and that they can access the best treatment indicated by their doctor. In our country, the issue of access is a frequent problem for many patients. Therefore, we celebrate that there are more alternatives that allow those who need therapy to receive them. ”

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