Development of biosimilars in an era of oncologic drug shortages

Li, Edward; Subramanian, Janakiraman; Anderson, Scott; Thomas, Dylan C.; McKinley, Jason D.; Jacobs, Ira

doi:10.2147/dddt.s75219

Cited by 37 publications

(29 citation statements)

References 37 publications

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“…These results are shown in Supplementary Table S5. A large percentage of these studies described approaches or methodologies for the characterization and development of biosimilars, as well as how to demonstrate biosimilarity with the originator molecule [67–71]. Additional studies provided examples of biosimilars and opinions on regulatory aspects of biosimilar development [72–80].…”

Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

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BackgroundBiologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access.ObjectivesThe purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer.MethodsMEDLINE®, Embase®, and ISI Web of Science® databases were searched to September 2015. Conference proceedings (17) were searched (2012 to July 2015). Searches of the United States National Library of Medicine ClinicalTrials.gov registry were also conducted. Risk of bias assessments were undertaken to assess data strength and validity.ResultsProposed biosimilars were identified in 23 studies (36 publications) in oncology and ten studies in 14 publications in oncology and chronic inflammatory diseases for bevacizumab, rituximab, and trastuzumab originators. Based on our review of the included published studies, and as inferred from the conclusions of study authors, the identified proposed biosimilars exhibit close similarity to their originators. Published data were also retrieved on intended copies of rituximab. It remains unclear what role these agents may have, as publications on rigorous clinical studies are lacking for these molecules.ConclusionWhile biosimilar products have the potential to improve patient access to important biologic therapies, robust evidence of outcomes for monoclonal antibody biosimilars in treating cancer patients, including data from comparative efficacy and safety trials, is not yet available in the published literature. Significant data gaps exist, particularly for intended copies, which reinforces the need to maintain a clear differentiation between these molecules and true biosimilars. As more biosimilars become available for use, it will be important for stakeholders to understand fully the robustness of overall evidence used to demonstrate biosimilarity and gain regulatory approval.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0207-0) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

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“…In addition, suboptimal compliance with current good manufacturing practice, changes in clinical standards, a greater demand for rituximab, and manufacturing delays are the most common factors that contribute to drug shortages 35. The supply of chemotherapeutics, such as 5-fluorouracil, liposomal doxorubicin, and fludarabine, as well as rituximab, may be adversely affected by looming drug shortages, with potentially pernicious outcomes for patients 36.…”

Section: Rituximab: Challenges For the Futurementioning

confidence: 99%

Rituximab in the treatment of follicular lymphoma: the future of biosimilars in the evolving therapeutic landscape

Subramanian¹,

Cavenagh²,

Desai

et al. 2017

CMAR

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Follicular lymphoma (FL) is the second most common type of non-Hodgkin’s lymphoma. FL is an incurable disease with treatment options ranging from a “watch-and-wait” approach to localized therapy with radiation or systemic therapy with rituximab in combination with chemotherapy regimens. This review summarizes the role of rituximab across the spectrum of FL treatment and the evolving therapeutic landscape with the emergence of novel agents currently in clinical development. Despite the prospect of new agents on the horizon, it is widely accepted that rituximab will remain as the cornerstone of therapy because of its established long-term efficacy. Many biologics, including rituximab, have lost exclusivity of composition-of-matter patent or will do so in the next few years, which is a concern for patients and physicians alike. Moreover, access to rituximab is challenging, particularly in countries with restricted resources. Together, these concerns have fueled the development of safe and effective biosimilars. The term “biosimilar” refers to a biologic product that is highly similar to an approved reference (or originator) product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences in purity, potency, or safety. Biosimilars are developed to treat the same condition(s) using the same treatment regimens as an approved reference biologic, and have the potential to increase access to more affordable treatment of FL. Herein, we also discuss the potential benefits of eagerly awaited rituximab biosimilars, which may mitigate the impact of the lack of access to rituximab.

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“…Drug supply problems are an increasing and worldwide problem [1–5]. Different definitions are used to define drug supply problems, also referred to as drug or medicine shortages [6].…”

Section: Introductionmentioning

confidence: 99%

Time spent by Belgian hospital pharmacists on supply disruptions and drug shortages: An exploratory study

et al. 2017

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IntroductionSupply problems of drugs are an increasing and worldwide problem, also in Belgium. Hospital pharmacists try to manage drug supply problems to minimize the impact on patient care. This study aims to quantify in a detailed manner how much time employees of 17 Belgian hospital pharmacies spend on drug supply problems.MethodsDuring six months, employees of Belgian hospital pharmacies filled in the daily time spent on drug supply problems using a template containing all steps which can be executed to manage drug supply problems. Additionally, Belgian hospital pharmacists were asked to report the drugs which experienced drug supply problems together with the solution for this problem.ResultsHospital pharmacists spent a median of 109 minutes a week on drug supply problems, with a minimum of 40 minutes per week and a maximum of 216 minutes per week. Fifty-nine percent of the total time spent on drug supply problems was executed by hospital pharmacists, 27% by pharmacy technicians; the rest was performed by logistic or administrative personnel. About one third of the total time spent was invested in gathering information on the supply problem. About two third of the supply disruptions caused drug shortages, meaning there was a need to switch to another (generic) therapeutic alternative. For most drug shortages, a Belgian generic medicine could be found. However in some cases, the alternative had to be ordered abroad or for some drug shortages, no alternative was available.ConclusionThese exploratory results on time spent by hospital pharmacists on drug supply problems in Belgium highlight the economic impact of drug supply problems for hospital pharmacies. A fully reliable, daily updated list on the federal agencies websites would be a major help to hospital pharmacists.

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Development of biosimilars in an era of oncologic drug shortages

Cited by 37 publications

References 37 publications

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Rituximab in the treatment of follicular lymphoma: the future of biosimilars in the evolving therapeutic landscape

Time spent by Belgian hospital pharmacists on supply disruptions and drug shortages: An exploratory study

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