Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab

Saleem, Tabinda; Qurashi, H.M.S.; Jamali, Mohsin M.; Gomez, Janet Chan; Kanderi, Tejaswi

doi:10.7759/cureus.9300

Cited by 6 publications

(7 citation statements)

References 16 publications

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“…Compared with conventional therapies, the costs of therapeutic mAbs and fusion proteins are very high, which may restrict the access of patients to optimal therapy for many serious diseases. One of the major drivers of high costs is the lack of sufficient competition in the biologicals market, especially among products that have lost patent and data protection [1,[4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

Kurki

Barry

Bourges³

et al. 2021

Drugs

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Background Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins. Objectives The aim of this study was to analyse the short-and long-term safety and interchangeability data of biosimilar mAbs and fusion proteins to provide unbiased information to prescribers and policy makers. Methods Data on the safety, immunogenicity and interchangeability of EU-licensed mAbs and fusion proteins were examined using European Public Assessment Reports (EPARs) and postmarketing safety surveillance reports from the European Medicines Agency (EMA). As recent biosimilar approvals allow self-administration by patients by the subcutaneous route, the administration devices were also analyzed. Results Prelicensing data of EPARs (six different biosimilar adalimumabs, three infliximabs, three etanercepts, three rituximabs, two bevacizumabs, and six trastuzumabs) revealed that the frequency of fatal treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of treatment, serious adverse events (SAEs), and main immune-mediated adverse events (AEs) were comparable between the biosimilars and their reference products. The availability of new biosimilar presentations and administration devices may add to patient choice and be an emerging factor in the decision to switch patients. Analysis of postmarketing surveillance data covering up to 7 years of follow-up did not reveal any biosimilar-specific adverse effects. No product was withdrawn for safety reasons. This is in spite of considerable exposure to biosimilars in treatmentnaïve patients and in patients switched from the reference medicinal product to the biosimilar. Analysis of data from switching studies provided in regulatory submissions showed that single or multiple switches between the originator and its biosimilar versions had no negative impact on efficacy, safety or immunogenicity. Conclusions In line with previous reports of prelicensing studies of biosimilar mAbs and etanercepts, this study demonstrated comparable efficacy, safety, and immunogenicity compared with the reference products. This is the first study to comprehensively analyze postmarketing surveillance data of the biosimilar mAbs and etanercept. An analysis of more than 1 million patient-treatment years of safety data raised no safety concerns. Based on these data, we argue that biosimilars approved in the EU are highly similar to and interchangeable with their reference products. Thus, additional systematic switch studies are not required to support the switching of patients.

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Section: Introductionmentioning

confidence: 99%

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

Kurki

Barry

Bourges³

et al. 2021

Drugs

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“…In 2009, bevacizumab was also approved as a treatment for glioblastoma multiforme (GBM) and renal cell carcinoma as a second-line treatment. Since then, several randomized clinical trials have shown that it improves survival, making it one of the most widely used oncologic drugs [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Intestinal Perforation: A Rare Complication of Treatment With Bevacizumab

Adhikari¹,

Ghose²,

Tekin³

et al. 2021

Cureus

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Bevacizumab, a monoclonal immunoglobulin-G1 antibody directed against vascular endothelial growth factor (VEGF), inhibits angiogenesis. Gastrointestinal perforation is a serious and often fatal adverse event related to bevacizumab use. Bevacizumab is indicated in the treatment of colorectal malignancies, certain subtypes of non-small cell lung carcinoma, metastatic renal cell carcinomas, and cervical cancers. It is also indicated in the treatment of recurrent glioblastoma (GBM) in adult patients as the sole treatment agent or in combination with other antineoplastic medications. We present a case of a patient on bevacizumab currently with glioblastoma multiforme and seizures, who was previously treated with radiation treatment and temozolomide. The patient presented to the emergency room with abdominal pain, seizures and was diagnosed to have an intestinal perforation.

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“…Drugs reported in these cases include amoxicillin/clavulanate and piperacillin/tazobactam (first patient), azithromycin (second patient), lopinavir (third patient), oseltamivir, lopinavir/ritonavir, azithromycin, ceftriaxone and piperacillin/tazobactam (fourth patient) and piperacillin/tazobactam, azithromycin and ceftriaxone (fifth case). These drugs could potentially have contributed to the development of HA in these patients, as already reported in literature [ 22 – 25 ]. However, there are no reported cases in which the use of these drugs may have triggered HA in patients with G6PDD.…”

Section: Discussionmentioning

confidence: 61%

Glucose-6-phosphate dehydrogenase deficiency and hydroxychloroquine in the COVID-19 era: a mini review

et al. 2021

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The coronavirus disease 2019 (COVID-19) is until today a global health emergency. In an immense effort, effective drugs against COVID-19 are searched and intensive researches on possible repurposing of antiviral agents are performed. Since chloroquine (CQ) and hydroxychloroquine (HCQ) have shown in vitro anti- COVID-19 activities, the potential effect of CQ/HCQ to treat and/or prevent COVID-19 infection has caused global attention. However, concern regarding possible hemolysis in G6PD-deficient COVID-19 patients exists and for this reason, the association between HCQ and G6PD deficiency (G6PDD) is back in the limelight. This study aims to answer the question raised by Mastroianni et al. “Hydroxychloroquine: Culprit or Innocent Bystander in G6PD-Deficient Patients with COVID-19?” , reporting all cases of HCQ in G6PD deficient COVID-19 patients published on PubMed (pubmed.ncbi.nlm.nih.gov), in addition to the Mastroianni’s patient. In our opinion, after an accurate revision of these cases and responding the question raised by Mastroianni et al., we believe that it is difficult to reach a final verdict about the definitive role of HCQ in these patients. The COVID-19 pandemic has reopened attention on HCQ use and G6PDD. G6PD status is extremely important in modulating the level of reactive oxygen species and many cellular immune responses such as enhanced production of the pro-inflammatory cytokine and inflammasome activation. Since these processes are involved in COVID-19 infection, acute hemolytic anemia, a severe complication of the G6PDD, can occur in these patients. In this context, the role of HCQ, usually effective, safe, and well tolerated in G6PD deficient patients, must be redefined in these patients with COVID-19.As consequence, answering the question: “ Hydroxychloroquine: Culprit or Innocent Bystander in G6PD-Deficient Patients with COVID-19?” , we state that it is risky to believe that HCQ may be an “innocent bystander” in G6PD-deficient COVID-19 patients.

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Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab

Cited by 6 publications

References 16 publications

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

Intestinal Perforation: A Rare Complication of Treatment With Bevacizumab

Glucose-6-phosphate dehydrogenase deficiency and hydroxychloroquine in the COVID-19 era: a mini review

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