Biosimilars in an Era of Rising Oncology Treatment Options

Peeters, Marc; Planchard, David; Pegram, Mark D.; Gonçalves, João; Jang, Harah

doi:10.2217/fon-2021-0546

Cited by 6 publications

(3 citation statements)

References 58 publications

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“…The EMA has approved biosimilars for filgrastim, bevacizumab, trastuzumab, pegfilgrastim, and rituximab. Since trastuzumab biosimilars first came out in Europe in 2018 [40].…”

Section: Regulatory Considerations Of National Medicines Agencies On ...mentioning

confidence: 99%

Cancer treatment with biosimilar drugs: A review

Malakar,

Gontor,

Dugbaye

et al. 2024

Cancer Innovation

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Biosimilars are biological drugs created from living organisms or that contain living components. They share an identical amino‐acid sequence and immunogenicity. These drugs are considered to be cost‐effective and are utilized in the treatment of cancer and other endocrine disorders. The primary aim of biosimilars is to predict biosimilarity, efficacy, and treatment costs; they are approved by the Food and Drug Administration (FDA) and have no clinical implications. They involve analytical studies to understand the similarities and dissimilarities. A biosimilar manufacturer sets up FDA‐approved reference products to evaluate biosimilarity. The contribution of next‐generation sequencing is evolving to study the organ tumor and its progression with its impactful therapeutic approach on cancer patients to showcase and target rare mutations. The study shall help to understand the future perspectives of biosimilars for use in gastro‐entero‐logic diseases, colorectal cancer, and thyroid cancer. They also help target specific organs with essential mutational categories and drug prototypes in clinical practices with blood and liquid biopsy, cell treatment, gene therapy, recombinant therapeutic proteins, and personalized medications. Biosimilar derivatives such as monoclonal antibodies like trastuzumab and rituximab are common drugs used in cancer therapy. Escherichia coli produces more than six antibodies or antibody‐derived proteins to treat cancer such as filgrastim, epoetin alfa, and so on.

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“…The EMA has approved biosimilars for filgrastim, bevacizumab, trastuzumab, pegfilgrastim, and rituximab. Since trastuzumab biosimilars first came out in Europe in 2018 [40].…”

Section: Regulatory Considerations Of National Medicines Agencies On ...mentioning

confidence: 99%

Cancer treatment with biosimilar drugs: A review

Malakar,

Gontor,

Dugbaye

et al. 2024

Cancer Innovation

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“…Oncology biosimilars have shown comparable efficacy and safety based on clinical evidence and physicochemical quality data in real-world settings [ 73 ]. With the increasing cost of cancer drugs worldwide, biosimilars have been widely utilized to somewhat control the increasing cost of cancer drugs.…”

Section: Availability and Cost Of Cancer Drugsmentioning

confidence: 99%

The State of Cancer Care in the United Arab Emirates in 2022

Al-Shamsi

2022

Clinics and Practice

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Cancer is the third-leading cause of death in the United Arab Emirates (UAE); cancer care in the UAE has evolved dramatically over the last 40 years, from a single center in Al Ain in 1981 to more than 30 cancer centers and clinics across the UAE, with at least four comprehensive cancer centers in the UAE nowadays. Despite the significant progress in medical care, cancer quality control across the UAE is still lacking, with significant variations in cancer care across the cancer centers. Access to clinical trials is still hampered by a lack of expertise and research infrastructure and a small population, which renders patient accrual for trials a major challenge. Education and training are other areas for improvement that require immediate attention, and, in this review, we try to address these critical aspects for stakeholders to consider better cancer care in the UAE. Early cancer detection and screening are still evolving in the UAE, and a national screening program is lacking. There is also a need to address barriers to screening and to consider less invasive screening methods such as approved blood-based screening, which is likely to be more acceptable to the UAE population. In this review, we also address new topics that have not been addressed previously, including oncology medical tourism, psycho-oncology, onco-fertility, precision oncology, survivorship, oncology nursing, cancer support programs, and the oncology sector’s response to the COVID-19 pandemic, all in the context of the UAE cancer landscape. Finally, we provide recommendations for policymakers, regulators, payers, patient advocacy groups, and the UAE oncology community regarding the delivery and future planning of high-quality cancer care. These recommendations are aligned with the UAE government’s vision to reduce cancer mortality and provide high-quality healthcare for its citizens and residents.

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“…The high cost of biologic drugs threatens the sustainability of high-quality care and may prevent patients from having access to optimal treatments. 1,2 With the introduction of lower-priced biosimilar agents, the potential to decrease the burden on health care expenditure and facilitate better access to effective treatments can be envisioned. Biosimilars are clinically equivalent to branded agents yet cost significantly less.…”

Section: Introductionmentioning

confidence: 99%

Sustainable Integration of US Food and Drug Administration–Approved Biosimilars: Pharmacy- Versus Physician-Driven Change

Waterhouse,

Ward,

Drosick

et al. 2023

JCO Oncology Practice

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PURPOSE Biosimilars are clinically equivalent to branded products yet cost significantly less. Interchangeability is a US Food and Drug Administration (FDA) designation that allows generic drugs to be substituted for reference drugs at the pharmacy, without a physician's consent. Currently, no oncologic biosimilar has FDA approval for interchangeability. METHODS Building on pharmacy auto-substitution processes with therapeutic interchange, Plan-Do-Study-Act methodology was used to automate conversions from reference biological products to Pharmacy and Therapeutics–/Physician-approved biosimilars. After establishing the baseline metrics, cycle 1 focused on full staff education (completed July 2020) with systematic pharmacy-driven biosimilar conversion initiated in September 2020 for rituximab, trastuzumab, and bevacizumab. Physician-initiated conversion of Neulasta biosimilar products was encouraged but not mandated. During cycle 2 (May 1, 2021-November 30, 2021), pharmacy-driven Neulasta biosimilar conversion was mandated. In cycle 3 (December 1, 2021-April 30, 2023), stakeholder education was reinforced and the sustainability of conversions was confirmed. RESULTS Systematic pharmacy-driven conversion to biosimilar products improved over cycles 1 and 2 from baseline: 1.8% to 90.3% for rituximab, 9.2% to 89.7% for trastuzumab, and 20.5% to 96.1% for bevacizumab. Physician-driven biosimilar conversion for Neulasta was lower at 12.7% through April 2021. Pharmacy-driven Neulasta biosimilar conversion was initiated during cycle 2, resulting in a conversion rate of 39.7%. The conversion rates remained sustainable through April 2023. CONCLUSION Pharmacy-driven auto-substitution of biosimilar products results in rapid and statistically significant biosimilar adoption. The pharmacy-based substitution approach was found to be far more effective than physician-driven substitution. Rapid conversion from branded products to FDA-approved biosimilar is feasible, measurable, and sustainable and can be scaled. Barriers to Neulasta conversion warrant further investigation.

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Biosimilars in an Era of Rising Oncology Treatment Options

Cited by 6 publications

References 58 publications

Cancer treatment with biosimilar drugs: A review

Cancer treatment with biosimilar drugs: A review

The State of Cancer Care in the United Arab Emirates in 2022

Sustainable Integration of US Food and Drug Administration–Approved Biosimilars: Pharmacy- Versus Physician-Driven Change

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