Patient access to rituximab in emerging markets

The study examined access to the anti-CD20 monoclonal antibody in the US and four other countries with varying resources. A total of 450 haematologists and oncologists completed the survey, which ran from July to August 2013: 150 in the US and 75 each in Brazil, Mexico, Russia and Turkey. The authors examined whether availability of a rituximab biosimilar would improve access to, and use of, the therapy [1]. Currently, access to rituximab is particularly challenging in countries with limited resources.

Rituximab is an important component of oncology treatment strategies and is commonly used to treat certain haematological malignancies. It is indicated for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) in both the European Union (EU) and the US.

Less than 40% of physicians who completed the survey agreed that rituximab was easy to access from a cost perspective. Many physicians chose not to treat, were unable to treat or had to modify treatment with rituximab despite guidelines recommending its use in NHL and CLL patients. Insurance coverage, reimbursement and cost to patient were commonly reported as barriers to the use of rituximab. Across all markets, over half of physicians reported that they would increase use of rituximab if a biosimilar was available.

The authors of the study conclude that rituximab use would increase across all therapy types and markets if a biosimilar was available. However, a biosimilar to rituximab would have the greatest impact in Brazil, Mexico and Russia since, of all markets examined, physicians from these countries were least likely to rate rituximab as easy to access from a cost perspective.

Biosimilars are commonly priced 25–30% less than the originator biological and are therefore likely to increase access to specific therapies by offering patients a more affordable treatment alternative. As biological patents expire in the EU and the US, the development and use of biosimilars is expected to grow substantially in the near future.

A biosimilar to rituximab would increase the use of rituximab in the oncology arena, particularly in emerging markets. A biosimilar to rituximab would address an unmet need in patients with CLL and NHL who currently do not receive rituximab, or receive less than optimal treatment with rituximab, due to insurance coverage or cost issues related to such treatment.

Pfizer is running clinical trials of a rituximab biosimilar for rheumatoid arthritis. Celltrion of South Korea, Teva of Israel, Merck and Sandoz are among a host of companies currently running clinical trials of rituximab biosimilars [2].

In fact, patient access to rituximab in Mexico and Russia may soon become easier. Russian biotechnology company Biocad announced in April 2014 that the company had received approval from the Russian Ministry of Health for its rituximab non-originator biological, AcellBia (BCD-20) [3]. While in Mexico, Probiomed already sells six non-originator biologicals, including Kikuzubam (rituximab) [4].

Conflict of interest
The authors of the research paper [1] declared that Baer is the Medical Director of research and innovation and Chief Medical Officer of MercyHealth-ClinXus, LLC. Baer has no conflicts of interests to declare. Maini has no conflicts of interests to declare. Jacobs is a full-time employee of Pfizer Inc.

Editor’s comment
It should be noted that ‘biosimilars’ or ‘non-originator biologicals’ approved in Mexico or Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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References
1.   Baer WH, Maini A, Jacobs I. Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (Basel). 2014;7(5):530-44.
2.   GaBI Online – Generics and Biosimilars Initiative. Biosimilars on the horizon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from:www.gabionline.net/Biosimilars/General/Biosimilars-on-the-horizon
3.   GaBI Online – Generics and Biosimilars Initiative. Biosimilar rituximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
4.   GaBI Online – Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America