Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

Bennett, Charles L.; Schoen, Martin W.; Hoque, Shamia; Witherspoon, Bartlett J.; Aboulafia, David M.; Hwang, Catherine S.; Ray, Paul S.; Yarnold, Paul R.; Chen, Brian; Schooley, Benjamin; Taylor, Matthew A.; Wyatt, Michael D.; Hrushesky, William J. M.; Yang, Y. Tony

doi:10.1016/s1470-2045(20)30485-x

Cited by 21 publications

(43 citation statements)

References 22 publications

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“… 22 Since 2013, the EU has labeled biosimilar oncologic drugs with a black triangle for monitoring long-term AEs. 11 In Brazil, patients and health care professionals are also encouraged to submit all AEs related to biologic drugs, despite the products not having a black triangle on the label. However, ANVISA and EMA require the inclusion of the Risk Management Plan for innovative biologic products and biologic products registered following the comparability pathway.…”

Section: Discussionmentioning

confidence: 99%

“… 10 The most recent Policy Review in oncology biosimilars addressed price discounts for biosimilars, which were reported to be the average of 30% in EU and 10%-33% in the United States. 11 Giuliani and Bonetti 39 assessed the pharmacologic costs of trastuzumab reference and biosimilar to be necessary to get the benefit in neoadjuvant breast cancer treatment. Combining the costs of therapy with the measure of efficacy (pathologic complete response), the costs of the trastuzumab biosimilar is about 40% less compared with that of the trastuzumab reference (3,283€ and 6,310€, respectively) for the whole neoadjuvant treatment.…”

Section: Discussionmentioning

confidence: 99%

“…Switching refers to the clinical action, that is, when the prescriber decides to exchange one drug for another. 11 Interchangeability is regulated by different national regulatory authorities in European Union, United States, and other countries. In the United States, FDA has created a regulatory designation pathway for the scientific evaluation of interchangeability, whereas in European Union, the responsibility for conferring interchangeability designation is delegated to individual member countries.…”

Section: Introductionmentioning

confidence: 99%

“…55, 6 which is based on accepted international standards, such as those of the WHO 7,8 and also meets most of the policy reviews on oncology biosimilars. [9][10][11] According to this resolution, innovative biologic products may follow the innovative pathway and biosimilar products may follow the comparability pathway. Following EMA and FDA, ANVISA requires an extensive comparison of the biosimilar with the reference product to demonstrate high similarity in chemical structure, biologic function, efficacy, safety, and immunogenicity.…”

Section: Introductionmentioning

confidence: 99%

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Biosimilar Use in Breast Cancer Treatment: A National Survey of Brazilian Oncologists' Opinions, Practices, and Concerns

Resende

Ladislau

Cardoso

et al. 2021

JCO Global Oncology

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PURPOSE Breast cancer is the most common malignancy in Brazilian women, with 66,280 new cases in 2020 (with 20% overexpressing human epidermal growth factor receptor 2 [HER2]). The trastuzumab biosimilar was the first oncology biosimilar approved in Brazil for HER2-positive breast cancer treatment. This study aimed to assess the current level of knowledge of biosimilars, comfort of use, extrapolation indications, and switching of practices among oncologists in Brazil. METHODS A 24-question survey was developed using an online platform that sought information regarding responders' characteristics and use of biosimilars. The survey analyzed the basic knowledge of biosimilars, trastuzumab biosimilars, level of comfort with extrapolation, switching treatment regimens, and opinions concerning the cost of HER2-positive breast cancer therapy. Data were collected between July and September 2019 and included 144 oncologists from five Brazilian regions. RESULTS In total, 95% of respondents could identify the most appropriate definition of biosimilars and 96% felt comfortable prescribing trastuzumab biosimilars. Although 63% of respondents would use the biosimilar in all settings wherein the reference biologic was approved, 35% would use the biosimilar for cases involving metastatic disease. Although 82% of oncologists were in favor of switching from a reference biologic to a biosimilar, 18% would avoid switching regimens. The lack of studies detailing switching to other regimens and the correct timing to switch was the major concern. The cost of HER2 therapy was a significant concern for most oncologists. CONCLUSION Oncologists demonstrated a high level of knowledge of biosimilars and encouraging levels of prescriber use; however, extrapolation and switching treatment regimens are barriers to the effective use of biosimilars in cancer treatment. Efforts should be concentrated on strategies involving medical education programs on biosimilars.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Biosimilar Use in Breast Cancer Treatment: A National Survey of Brazilian Oncologists' Opinions, Practices, and Concerns

Resende

Ladislau

Cardoso

et al. 2021

JCO Global Oncology

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“…Mature epoetin biosimilar markets have existed in European Union (EU) countries since 2007, as five epoetin biosimilar formulations have received regulatory authorizations in EU countries [2,3]. Biosimilar epoetins account for 45% of EU epoetin sales (varying by country) [3,4]. Similarly, oncology biosimilar uptake in the U.S. for filgrastim was rapid, accounting for 52% market share at 18 months.…”

Section: Introductionmentioning

confidence: 99%

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

et al. 2021

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Biosimilars are biologic drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety, and efficacy. Biosimilar epoetin received Food and Drug Administration (FDA) approval in 2018. The manufacturer received an FDA nonapproval letter in 2017, despite receiving a favorable review by FDA's Oncologic Drugs Advisory Committee (ODAC), and an FDA nonapproval letter in 2015 for an earlier formulation. We discuss the 2018 FDA approval, the 2017 FDA ODAC Committee review, and the FDA complete response letters in 2015 and 2017; review concepts of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance; review European and U.S. oncology experiences with biosimilar epoetin; and review the safety of erythropoiesis-stimulating agents. In 2020, policy statements from AETNA, United Health Care, and Humana indicated that new epoetin oncology starts must be for biosimilar epoetin unless medical need for other epoetins is documented. Empirical studies report that

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Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Luo,

Du,

et al. 2023

JAMA Netw Open

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ImportanceThe high cost of biologics used to treat cancer has been an increasing burden in the world. In China, the recent approval of cancer biosimilar drugs to resolve this problem is promising, but evidence of clinical benefits, price, and uptake for these drugs is still lacking.ObjectivesTo compare characteristics of pivotal clinical trials in China and other countries for biosimilars of bevacizumab, rituximab, and trastuzumab and investigate the efficacy or effectiveness, safety, and immunogenicity outcomes of cancer biosimilars compared with reference drugs by meta-analysis.Data SourcesFor this systematic review and meta-analysis, PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for published studies from database inception to February 1, 2023, using the search topics (cancers) AND (biosimilars).Study SelectionRandomized clinical trials and cohort studies that included patients with cancer were included.Data Extraction and SynthesisTwo authors independently extracted the outcome estimates and characteristics for each study. A random-effects meta-analysis was performed to summarize the relative estimates with 95% CIs. This study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline.Main Outcomes and MeasuresClinical trial characteristics were collected for biosimilars of bevacizumab, rituximab, and trastuzumab. The relative estimates of efficacy or effectiveness (objective response rate, progression-free survival, and overall survival), safety, and immunogenicity outcomes were analyzed for biosimilars vs reference drugs. The weighted average price and uptake rate were evaluated for biosimilars relative to their reference drugs between 2015 and 2022.ResultsA total of 39 RCTs (involving 18 791 patients) and 10 cohort studies (involving 1998 patients) were included. The biosimilars of bevacizumab (16 RCTs; risk ratio [RR], 0.97; 95% CI, 0.93-1.01; P = .17), rituximab (12 RCTs; RR, 1.03; 95% CI, 0.98-1.08; P = .70), and trastuzumab (9 RCTs: RR, 1.04; 95% CI, 0.97-1.12; P = .29) met equivalence with reference biologics in regard to the objective response rate. The results summarized from cohort studies were consistent with those from RCTs. In 2022, cancer biosimilars were priced at 69% to 90% of the costs for the reference drugs, and their uptake reached 54% to 83% in China.Conclusions and RelevanceThis systematic review and meta-analysis indicated that cancer biosimilars provided comparable clinical benefits at lower prices compared with reference drugs. These findings suggest the potential feasibility of expediting the transition from reference drugs to biosimilars to benefit more patients with cancer.

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Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

Cited by 21 publications

References 22 publications

Biosimilar Use in Breast Cancer Treatment: A National Survey of Brazilian Oncologists' Opinions, Practices, and Concerns

Biosimilar Use in Breast Cancer Treatment: A National Survey of Brazilian Oncologists' Opinions, Practices, and Concerns

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

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