The Concept of Biosimilars: From Characterization to Evolution—A Narrative Review

Farhat, Fadi; Torres, Alfredo; Park, Wungki; Lopes, Gilberto; Mudad, Raja; Ikpeazu, Chukwuemeka; Aad, Simon Abi

doi:10.1634/theoncologist.2017-0126

Cited by 33 publications

(25 citation statements)

References 28 publications

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“…The main theoretical dilemma of clinicians regarding interchangeability, especially in multiple switches and at the pharmacy level, is the fear of the eventual inducement of immune reaction responses (immunogenicity) and their potential consequences in terms of safety and efficacy [ 59 ]. However, it is important to note that immunogenicity might be a consequence of several factors like underlying disease, genetic background, age, immune status, including immunomodulating therapy, dosing schedule and structural and manufacturing structural homology, post-translational modifications, modification of the native protein, formulation, and impurities [ 1 , 59 , 60 ]. Not just biosimilars but also biologics could have immunogenic properties [ 59 , 60 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Halimi

Daci

Netkovska

et al. 2020

IJERPH

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Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

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Section: Discussionmentioning

confidence: 99%

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Halimi

Daci

Netkovska

et al. 2020

IJERPH

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“…There are some important differences between biologics, biosimilars and generic drugs. Biologics are large molecules with structural complexity with active drug substance made by or derived from a living organism (2). Biologics are mAb, immunomodulators, therapeutic proteins and growth factor substances derived from living organisms.…”

Section: Biologics Biosimilars and Genericsmentioning

confidence: 99%

“…Biosimilars are alternatives of originator biologics, but not generic versions of originator. Biosimilars are highly similar copies of biological medicines, equally effective and safe (2). The biosimilar product is highly similar to the reference product and minor differences in its clinically inactive components are accepted, but without any clinically meaningful differences (9).…”

Section: Biologics Biosimilars and Genericsmentioning

confidence: 99%

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Biosimilars in dermatology: The wind of change (Review)

et al. 2019

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Biosimilars are new drugs, highly similar copies of biological medicines, equally effective and safe but at lower prices. The aim of this brief review is to provide the current status of biosimilars approved in the European Union for dermatological use. We used PubMed for literature search up to June 2018. The keyword 'biosimilars' was searched and 1,691 items were found. From the 1,691 studies, we included 34 articles in our review. Biologics, biosimilars and generics are different types of drugs. Biosimilars are complex molecules produced by a difficult manufacturing process, and changes in product quality may affect its safety and efficacy. Now, there are 9 biosimilar medicines approved by European Medicines Agency (EMA) for plaque psoriasis and hidradenitis suppurativa: Amgevita, Solymbic, Cyltezo, Imraldi, Benepali, Erelzi, Flixabi, Inflectra and Remsima, and the number is increasing. In 2005, EMA issued the first guidelines for approval of biosimilars. Next-generation biologics, called 'biobetters', have the same target or mechanism of action as previously approved biologics, but they have structural changes and an improved formulation. The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world. Contents 1. Introduction 2. Literature search 3. Biologics, biosimilars and generics 4. Manufacturing biosimilars 5. Biosimilar medicines used in dermatology approved by EMA 6. The future pathway ahead 7. Conclusions

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“…Taking advantage of the biosimilar movement would see Bangladesh keep up with other growing Southeast Asian pharmaceutical industries (such as those of India, Vietnam and Thailand) seeking the clinical and economic benefits of biosimilars [21]. However, there is currently a large gap in documented literature of the country’s biosimilar need, usage, regulatory policy and post marketing surveillance strategies which we aim to fill through this study.…”

Section: Case Study: Bangladesh Pharmaceutical Industrymentioning

confidence: 99%

An Empirical Analysis of the Perceived Challenges and Benefits of Introducing Biosimilars in Bangladesh: A Paradigm Shift

2018

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The high demand for and resulting financial success of biopharmaceutical products over the last three decades have seen the door open for close copies of these biological products, also known as biosimilars. This paper seeks to collate all relevant published intelligence with acquired survey data to assess the weight of available evidence that these products hold immense potential for the pharmaceutical industry in terms of their applications and benefits. Biosimilars also pose to be of great promise to the Bangladesh pharmaceutical industry, with the commitment of drastically reducing its dependence on foreign imports of biopharmaceutics to meet local demand. Our questionnaire based survey involved 100 Clinicians, 50 Industry Experts and 100 Academicians. The study found that majority of Industry Experts (72%) and Academicians (63%) shared a different concept of biosimilars opposed to majority of Clinicians (78%). Majority of Academicians (68%) and Industry Experts (61%) also shared a different belief from that of most Clinicians (61%) regarding the need for updating the existing regulatory guidelines. The study also showed that Clinicians (67%), Industry Experts (83%) and Academicians (80%) highlighted the benefit of lower costs of biosimilars. Furthermore, the quality data obtained from the survey results allowed us to evaluate and provide recommendations for stakeholders on the need for increased biosimilar awareness, pharmacovigilance and safety in Bangladesh.

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The Concept of Biosimilars: From Characterization to Evolution—A Narrative Review

Abstract: This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost.

Cited by 33 publications

References 28 publications

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

Biosimilars in dermatology: The wind of change (Review)

An Empirical Analysis of the Perceived Challenges and Benefits of Introducing Biosimilars in Bangladesh: A Paradigm Shift

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