Safety of switching between rituximab biosimilars in cancer

Biosimilars/General | Posted 07/05/2021 post-comment0 Post your comment

In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals [1]. However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) [2].

Cancer Cell V13I20

Although there are multiple contributing factors [3], the slow uptake of biosimilars is likely due in part to the fact that patients and healthcare professionals have at times been subjected to incomplete information about biosimilars [4].

The equivalence between reference rituximab (MabThera) and its biosimilars has been demonstrated in randomized, double-blind, controlled trials [5-8].

In order to build patient and physician confidence, haematologists and pharmacists from Italy carried out a prospective observational study at the Trento General Hospital in Italy [9]. The study documented any adverse event (AE) reported in association with the use of the rituximab biosimilars Truxima (Mundipharma) and Rixathon (Sandoz) and with the practice of switching between different products in patients with non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).

A total of 83 patients (72 NHL and 11 CLL) received rituximab and were included in the study between March 2018 and March 2019. The study population received 465 rituximab infusions, and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. A total of 146 AEs were reported in 71 patients (84.5%) during the study period. The AEs reported were similar in terms of seriousness and frequency, regardless of rituximab formulation and switching.

Data from post-marketing studies and real-world experience are needed to provide additional information to supplement the strong evidence already obtained on biosimilars from randomized controlled trials.

The increasing availability of biosimilars has led to significant healthcare savings and has provided greater patient access to high-cost therapeutics [10].

A cost-analysis study conducted in Europe, predicted that switching to a rituximab biosimilar would save Euros 56.82 million over a year [11].

The authors concluded that ‘in the setting of our haematology unit of a general hospital, this shared approach has increased clinicians and patients confidence in biosimilars with respect to safety, generating at the same time a 45% reduction in the price of rituximab (around 400,000 euros savings in one year)’.

Conflict of interest
The authors of the research paper [9] declared that there was no conflict of interest.

Abstracted by Silvana AM Urru, Hospital Pharmacy Unit, Trento General Hospital, Autonomous Province of Trento, Trento, Italy and the School of Hospital Pharmacy, University of Sassari, Sassari, Italy.

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LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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References
1. Biosimilars Medicines Group, A Medicines for Europe sector group. Docket submission and presentation to the Oncologic Drugs Advisory Committee meeting of 13 July 2017 [homepage on the Internet]. [cited 2021 May 7]. Available from: www.regulations.gov/document?D=FDA-2017-N-2732-0006
2. Moots R, Azevedo V, Coindreau JL, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep. 2017;19(6):37.
3. Association for Affordable Medicines. Failure to launch-barriers to biosimilar market adoption. September 2019 [homepage on the Internet]. [cited 2021 May 7]. Available from: www.biosimilarscouncil.org/wp-content/uploads/2019/09/AAM-Biosimilars-Council-Failure-to-Launch-2-web.pdf
4. Cohen HP, McCabe D. The importance of countering biosimilar disparagement and misinformation. BioDrugs. 2020;34(4):407-14.
5. Smolen JS, Cohen SB, Tony HP, et al. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017;76(9):1598-602.
6. Park W, Božić-Majstorović L, Milakovic D, et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018;10(6):934-43.
7. Jurczak W, Moreira I, Kanakasetty GB, et al. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017;4(8):e350-e361.
8. Ogura M, Sancho JM, Cho SG, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018;5(11):e543-e553.
9. Urru SAM, Spila Alegiani S, Guella A, et al. Safety of switching between rituximab biosimilars in onco-hematology. Sci Rep. 2021;11(1):5956.
10. IQVIA. Troein P. The impact of biosimilar competition in Europe [homepage on the Internet]. [cited 2021 May 7]. Available from: www.ec.europa.eu/docsroom/documents/38043
11. Janjigian YY, Bissig M, Curigliano G, et al. Talking to patients about biosimilars. Future Oncol. 2018;14(23):2403-14.

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