Lung cancer : Place of biosimilars in the therapeutic arsenal.

 Lung cancer : Place of biosimilars in the therapeutic arsenal.

 

According to the WHO, lung cancer is one of the 5 most common cancers in the world.

World (1). It requires heavy multidisciplinary care and is the source of significant expenditure, which thus constitutes a real public health problem either at the international level or in developing countries such as Morocco.

Lung cancer usually starts in the cells that line the bronchi and parts of the lung like the bronchioles or alveoli. There are two main types of primary lung cancer (2):

• Small cell lung cancer (SCLC): this type takes its name from the small cells that compose it and which are visible under a microscope.

• Non-small cell lung cancer (NSCLC): this is the most common type of lung cancer, accounting for 85-90% of all lung cancers.

 In 2018, the number of new cases of lung cancer diagnosed worldwide was estimated at more than 470,000 (2) To reach more than 19,000,000 in 2020 (see Figure 1) for both sexes, with a percentage of 11.4% (3).

 

 

 

 

In Morocco, in 2020, 7353 cases were recorded for both sexes (see Figure 2) (3).

 

 

 

 

 

Today, precision medicine adapts to the biological and pathological characteristics of the 

 

patient, it is the biosimilar products resulting from immunotherapies and targeted therapies 

 

that have taken place in the treatment of cancers.

 

The objective of our work is to verify and identify the place of biosimilars in the therapeutic 

 

arsenal against lung cancer.

 

 

I-Problem:

 

A biosimilar medicine is a medicine which, like any biological medicine, is produced from a 

 

cell, a living organism or derived from them (4).

 

Its efficacy and adverse effects are equivalent to those of its reference biological drug. Its 

 

marketing authorization meets strict regulatory requirements in order to demonstrate that its 

 

pharmaceutical quality, its efficacy and its adverse effects are clinically equivalent to those of 

 

the reference biological drug (4).

 

It is possible to change a biological medicine for another appearing on the list of biosimilar 

 

medicines, which defines interchangeability (4).

 

Biosimilar drugs have made it possible to successfully treat certain types of cancer. They 

 

complement the therapies used so far (chemotherapy, for example), but cannot, however, 

 

replace them.

 

 

Research question: What is the place of Biosimilars in the treatment of lung cancer? 

 

The management of lung cancer, as for almost all cancers, involves 3 main areas: surgery, 

 

chemotherapy, radiotherapy. These three types of treatment have the specificity of having to 

 

be used either for systemic purposes (the whole body) or for locoregional purposes (a 

 

particular part or organ).

 

Bevacizumab, a recombinant humanized monoclonal antibody targeting vascular endothelial 

 

growth factor (VEGF), is approved for the treatment of non-squamous non-small cell lung 

 

cancer, there are biosimilars of bevacizumab on the international market in pulmonary 

 

oncology , are they also effective and secure.

 

II-Assumptions

 

 Biosimilars have an impact on the quality of life of lung cancer patients.

 Biosimilars have an economic interest in public health.

 

III-Methodology

 

When preparing our research for our thesis on "the place of biosimilars in the therapeutic 

 

arsenal against lung cancer", we used the bibliographic review available on the net.

 

Indeed, below are the sites we used for our research:

 

 Google scholar

 Advertising

 WHO

 Cairns

 ELSEVIER

 Medicare & Medicaid Services (CMS); https://www.cms.gov/

 ASCO (American Society of Clinical Oncology), www.asco.org.

 ESMO (European Society for Medical Oncology) https://www.esmo.org.

 www.drugs.com

 Review of scientific articles

 Reviews of theses already published

By doing our research; in French and English; we used the list of keywords below:

 Biosimilars in oncology

 Small Cell Lung Cancer (SCLC)

 Non-small cell lung cancer (NSCLC)

 NSCLC Treatment

 NSCLC Biosimilar Treatment

 Biosimilars used in Oncology

 Biosimilars impact

 Bronchial cancer, Angiogenesis, Bevacizumab, Endothelial growth factor, Chemotherapy.

 Bevacizumab.

 Endothelial growth factor

 Chemotherapy

 Targeted therapies in oncology

 Antibodies - Monoclonal and Lung Cancer

 CPNPC statistics

 Epidemiology of lung cancer

 Biosimilar and reference biological product

 Regulation of biosimilars

 Pharmacoeconomics of Biosimilar products

 

 Reimbursement of biosimilar products in oncology

 

Finally, we have excluded all articles that address cancer in general including other types of cancer (ovarian, uterus, CRC, breast, etc.) and we have kept and exploited only scientific articles relating to non-small cell lung cancer (SCPNC) and Small Cell Lung Cancer (SCLC) while limiting the treatment of the latter with biosimilar drugs.

 

The Avastin biosimilar came into being with the aim of improving accessibility for patients in relation to the cancer drug, not only accessibility in terms of availability but also affordability. In Morocco in 2017, the SOTHEMA laboratory launched Ypeva as a biosimilar to Avastin. Ypeva is considered among the first cancer biosimilars manufactured in Morocco. A bevacizumab biosimilar (Mvasi®) has also been approved by the EMA as an alternative to the reference Avastin®. Currently there are 2 biosimilars of Avastin in Europe: Mvasi and Zi-rabrev (11). The immune response of biosimilars Immune response is assessed during biosimilar development, in accordance with regulatory requirements, increased immune response is one of the main concerns expressed when switching between a reference biologic drug and a biosimilar drug (12) therefore, immune response data are required for regulatory approval of biosimilars and post-marketing surveillance is performed (13). Limitation of Biosimilar Bevacizumab Admittedly, biosimilars are proven to have no clinically meaningful differences in safety and efficacy with the reference product, however, to our knowledge, there is limited comparative analysis regarding adverse events for biosimilars bevacizumab and the reference product. Indeed, incidences of hypertension and proteinuria have been demonstrated in patients treated by reference compared to the biosimilar bevacizumab in order to potentially rationalize clinical management. In this sense, a higher risk of hypertension and proteinuria was associated with the bevacizumab reference product group, although not statistically significant. A shorter onset of hypertension and proteinuria was associated with the bevacizumab group of biosimilars. These findings require further validation in larger cohorts, particularly given the more recent implementation of bevacizumab biosimilars (14).

 

biosimilars, with a view to generalizing the use of this type of product, facilitate access to care and innovation for patients (18). While lung cancer remains the deadliest, it is also the one that has benefited from the greatest therapeutic advances over the past 15 years(19). Targeted therapies have revolutionized the management of patients with a genomic alteration but are only intended for a limited proportion of patients. These new molecules have already become the new standard in second line but also in first line in patients selected on the expression of PD-L1. (19).

 

 

VI-CONCLUSION

 

Biosimilars have taken their place in the therapeutic arsenal against lung cancer, but to date cannot replace treatment with radiotherapy and chemotherapy, they contribute to an improvement in the survival of cancer patients. of the lung, but remain without significant contribution to the quality of their life, it is still necessary to multiply the time and the money to manage to introduce even more efficient biosimilars in terms of quality, safety and efficacy and which will be able to increase the qualy of sick patients .

Despite the introduction of less expensive biosimilar agents into the lung cancer therapeutic armamentarium, which offers the potential to ease the expense burden and facilitate access to care for the majority of patients, there are still categories of poor patients who do not have the financial means to access this type of treatment.

   

Bibliographic references 

 

(1) https://www.who.int/en/news-room/fact-sheets/detail/cancer

(2) https://www.esmo.org/content/download/7250/143186/1/FR-Cancer-du-Lung-Non-%C3%A0-Petites-Cellules-Guide-pour-les-Patients. pdf

(3) Cancer today: https://gco.iarc.fr/today/online-analysis-pie?v=2020&mode=cancer&mode_population=continents&population=900&populations=&key=total&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group% 5B%5D=0&ages_group%5B%5D=17&nb_items=7&group_cancer=1&include_nmsc=1&include_nmsc_other=1&half_pie=0&donut=0

(4) https://www.has-sante.fr/jcms/c_2807411/fr/les-medicaments-biosimilaires#:~:text=Un%20m%C3%A9dicament%20biosimilaire%20est%20un,son%20m% C3%A9drug%20biological%20of%20r%C3%A9f%C3%A9rence

(5) 2. Taieb J, et al. Clin Colorectal Cancer. 2020;S1533-0028:30143–2).

(6) https://touchoncology.com/wp-content/uploads/sites/2/2021/03/TO_TE_Biosimilars-solid-tumours_Slides_March2021_EN.pdf

(7) M. Pérol, D. Arpin, Bevacizumab and non-small cell lung cancer: a new stage?, Revue des Maladies Respiratoires, Volume 26, Issue 2, 2009, Pages 125-138)

(8) https://pubmed.ncbi.nlm.nih.gov/29574193/

(9) https://www.santelog.com/actualites/cancer-du-poumon-des-anti-angiogeniques-aussi-efficaces-mais-moins-couteux

(10) https://www.centerforbiosimilars.com/view/patient-provider-surveys-elucidate-biosimilar-switching-process-in-oncology

(11) http://wd.fmpm.uca.ma/biblio/theses/annee-htm/FT/2020/these55-20.pdf

(12) Barber L, et al. Clin Pharmacol Ther. 2020;108:734–55

(13) European Medicines Agency; https://touchoncology.com/wp-content/uploads/sites/2/2021/03/TO_TE_Biosimilars-solid-tumours_Slides_March2021_EN.pdf

(14) (Man Y, Yu H, Mukherjee S, Zalewski O. Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar. J. Clin. Oncol. 39(Suppl. 3), 83–83 (2021).

(15) US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry (April 2015). www.fda.gov/media/82647/download]

(16) https://www.centerforbiosimilars.com/view/patient-provider-surveys-elucidate-biosimilar-switching-process-in-oncology

(17) Barbier L, et al. Clin Pharmacol Ther. 2020;108:734–55

(18) THESIS /Study of "cost-effectiveness" of drugs

(19) N. Guibert, M. Delaunay, J. Mazières, Immunotherapy and lung cancer: where are we?, Journal of Respiratory Diseases News, Volume 9, Issue 2, 2017, Pages 315-324, ISSN 1877- 1203, https://doi.org/10.1016/S1877-1203(17)30063-0.(https://www.sciencedirect.com/science/article/pii/S1877120317300630)