Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region

Farhat, Fadi; Othman, Ahmad; Karak, Fadi El; Kattan, Joseph

doi:10.1186/s40064-016-3779-8

Cited by 23 publications

(31 citation statements)

References 9 publications

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“…The low use of biologics in the region may be due to drug access, monitoring issues, and development of tuberculosis in endemic populations [ 23 ]. In some countries, including Lebanon, regulatory pathways for approval exist only in draft form [ 25 ].…”

Section: Resultsmentioning

confidence: 99%

Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries

et al. 2018

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The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologic medicines. However, as well as a lack of real-world data on the use of biosimilar medicines in practice, the availability of intended copies in the region may undermine physician confidence in prescribing legitimate biosimilar medicines. There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely. Therefore, a literature search was performed with the aim of providing important recommendations for the regulation and use of biosimilar medicines in the Middle East from key opinion leaders in rheumatology from the region. These recommendations focus on improving the availability of relevant real-world data, ensuring that physicians are aware of the difference between intended copies and true biosimilars and ensuring that physicians are responsible for making any prescribing and switching decisions.Electronic supplementary materialThe online version of this article (10.1007/s10067-018-3982-9) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries

et al. 2018

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“…AF.2A1 bound efficiently to various types of therapeutic IgG such as mAb_A, mAb_B, and mAb_C because of its ability to recognize the non-native structure of the Fc region of IgG 16 . This technique is also useful to evaluate the comparability between the prescribed original IgG and biosimilars, as the demand for biosimilars continues to increase in the pharmaceutical market 40 . Because the quality of biosimilars is significantly affected by changes in the manufacturing process and storage conditions, AF.2A1-AlphaScreen makes it possible to test a number of experimental conditions 41 .…”

Section: Discussionmentioning

confidence: 99%

AlphaScreen-based homogeneous assay using a pair of 25-residue artificial proteins for high-throughput analysis of non-native IgG

Senga

Imamura

Miyafusa

et al. 2017

Sci Rep

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Therapeutic IgG becomes unstable under various stresses in the manufacturing process. The resulting non-native IgG molecules tend to associate with each other and form aggregates. Because such aggregates not only decrease the pharmacological effect but also become a potential risk factor for immunogenicity, rapid analysis of aggregation is required for quality control of therapeutic IgG. In this study, we developed a homogeneous assay using AlphaScreen and AF.2A1. AF.2A1 is a 25-residue artificial protein that binds specifically to non-native IgG generated under chemical and physical stresses. This assay is performed in a short period of time. Our results show that AF.2A1-AlphaScreen may be used to evaluate the various types of IgG, as AF.2A1 recognizes the non-native structure in the constant region (Fc region) of IgG. The assay was effective for detection of non-native IgG, with particle size up to ca. 500 nm, generated under acid, heat, and stirring conditions. In addition, this technique is suitable for analyzing non-native IgG in CHO cell culture supernatant and mixed with large amounts of native IgG. These results indicate the potential of AF.2A1-AlphaScreen to be used as a high-throughput evaluation method for process monitoring as well as quality testing in the manufacturing of therapeutic IgG.

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“…Biosimilars are used widely in the Middle East 47 and in Asia. 48 Reasons for use include lower price relative to reference biologics and bioequivalence of efficacy and safety.…”

Section: Biosimilar Use In Other Regionsmentioning

confidence: 99%

“… 48 Reasons for use include lower price relative to reference biologics and bioequivalence of efficacy and safety. 47 Regulatory approvals, where needed, are largely modeled after US FDA and EMA guidelines. 48 …”

Section: Biosimilar Use In Other Regionsmentioning

confidence: 99%

The role of biosimilars in value-based oncology care

Patel¹,

Arantes²,

Tang³

et al. 2018

CMAR

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Biopharmaceuticals (biologics) represent one of the fastest growing sectors of cancer treatment. They are recommended for treating underlying cancer and as supportive care for management of treatment side effects. Given the high costs of cancer care and the need to balance health care provision and associated budgets, patient access and value are the subject of discussion and debate in the USA and globally. As the costs of biologics are high, biosimilars offer the potential of greater choice and value, increased patient access to treatment, and the potential for improved outcomes. Value-based care aims to improve the quality of care, while containing costs. The Centers for Medicare & Medicaid Services (CMS) has developed value-based care programs as alternatives to fee-for-service reimbursement, including in oncology, that reward health care providers with incentive payments for improving the quality of care they provide. It is anticipated that CMS payments in oncology care will be increasingly tied to measured performance. This review provides an overview of value-based care models in oncology with a focus on CMS programs and discusses the contribution of biosimilars to CMS value-based care objectives. Biosimilars may provide an important tool for providers participating in value-based care initiatives, resulting in cost savings and efficiencies in the delivery of high-value care through expanded use of biologic treatment and supportive care agents during episodes of cancer care.

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Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region

Cited by 23 publications

References 9 publications

Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries

Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries

AlphaScreen-based homogeneous assay using a pair of 25-residue artificial proteins for high-throughput analysis of non-native IgG

The role of biosimilars in value-based oncology care

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