Biosimilars in cancer treatment in Europe and the US

Home/Reports | Posted 07/03/2024 post-comment0 Post your comment

The World Health Organization's (WHO) most recent projections suggest a staggering 77% surge in new cancer cases globally by 2050, compared to the approximate 20 million recorded in 2022. As a result, the anticipated number of cancer-related deaths worldwide is poised to double to around 18.5 million by 2050, in contrast to the 9.7 million reported in 2022. Alarmingly, numerous countries still lack sufficient resources allocated to treatment and care services.

Cancer image015

Biological therapy for cancer uses the body's immune system to eliminate cancer cells and is effective across various types of cancer. As patents for numerous originator biological therapies have expired, cancer biosimilars offer broader accessibility at reduced costs.

Biosimilars, which are essentially similar versions of original biological medicines, have become widely used across the globe in treating various diseases, including cancer. Their adoption began in Europe back in 2006 and later expanded to the United States in 2015.

People undergoing cancer treatment may opt for either the original biological drugs or their biosimilar counterparts to manage their condition and alleviate side effects of cancer treatment. Biosimilars are administered in the same dosage and manner as the original biological, ensuring consistency in treatment.

Using biosimilars provides cost-saving benefits due to reduced development costs compared to original biologicals, enabling competitive pricing and lowering healthcare expenses. This competition in pricing also drives down overall healthcare costs, potentially increasing access to treatments and indirectly supporting cancer patients by bolstering healthcare infrastructure and resources.

The availability of numerous approved biosimilars for cancer treatment in both Europe (39) and the US (22) indicates a growing acceptance and trust among doctors and pharmacists in their quality, safety, and efficacy, on par with their original counterparts.

To date, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have approved several biosimilars for the treatment of cancer. These biosimilars have undergone rigorous evaluation and have been deemed comparable to their reference biologic drugs in terms of safety, efficacy, and quality. Table 1 is listing the biosimilars that have received approval for use in cancer patients in Europe and the US.

Table 1: Cancer biosimilars approved in Europe and the US*
Biosimilars Biosimilars used to treat cancer Biosimilar brand name
Europe USA
Bevacizumab Colon, breast, lung, kidney, ovarian and cervical cancers Abevmy, Alymsys, Aybintio, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev Alymsys, Mvasi, Vegzelma, Zirabev
Epoetin alfa and epoetin zeta Low levels of healthy red blood cells (called anaemia) that are caused by chemotherapy treatment

Epoetin alfa: Abseamed, Binocrit, Epoetin Alfa Hexal 

Epoetin zeta: Retacrit, Silapo

Epoetin alfa: Retacrit
Filgrastim and peg­filgrastim Low levels of white blood cells called neutrophils (neutropenia) that are caused by certain types of chemotherapy treatment

Filgrastim: Accofi­l, Filgrastim Hexal, Grastofi­l Nivestim, Ratiograstim, Tevagrastim, Zarzio

Pe­gfilgrastim:
Cegfi­la, Fulphila, Grasustek, Nyvepria, Pelgraz, Pelmeg, Stimufend, Ziextenzo

Filgrastim: Nivestym, Releuko, Zarxio

Pegfil­grastim: Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca Ziextenzo

Rituximab Certain types of blood cancers: CD20 positive B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL) Blitzima, Rixathon, Riximyo, Ruxience, Truxima Riabni, Ruxience, Truxima
Trastuzumab Certain types of breast and stomach cancers Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera
*until August 2023

 

All these biosimilars offer healthcare providers and patients more options for cancer treatment, potentially increasing access to effective therapies while also contributing to cost savings within healthcare systems.

Since August 2023, additional cancer biosimilars have been approved. On 6 December 2023, the US Food and Drug Administration (FDA) approved China-based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn) [2]. The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023, developed by EirGenix, Inc [3].

Related article
The successful uptake of biosimilars in Europe and the US

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: El recorrido del biológico de continuación Pectuna (pertuzumab) en Irán

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: El recorrido del biológico de continuación Pectuna (pertuzumab) en Irán

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

References
1. Al-Naqqash M, Castañeda-Hernández G, Chiang SC, et al. Plain language review: what are biosimilar medicines and how can they be used to treat people with cancer? Future Oncol. 2023 Nov 27. doi: 10.2217/fon-2023-0756. Epub ahead of print. PMID: 38010143.
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 7]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
3. GaBI Online - Generics and Biosimilars Initiative. EC approval of trastuzumab biosimilar Herwenda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 7]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-trastuzumab-biosimilar-herwenda

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010