Biosimilars in cancer treatment in Europe and the US

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.

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
Biosimilars	Biosimilars used to treat cancer	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].

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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

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