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

Zorkany, Bassel El; Ani, Nizar Al; Emadi, Samar Al; Saleh, Jamal Al; Uthman, Imad; Dershaby, Yasser El; Mounir, Mohamed; Moallim, Hani Al

doi:10.1007/s10067-018-3982-9

Cited by 19 publications

(35 citation statements)

References 39 publications

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“…To monitor AEs and to attribute them to the correct product, improved pharmacovigilance efforts are still largely needed in the era of biosimilars, although some advances have been made [ 77 ]. Accordingly, a number of medical societies have proposed requirements for postmarketing surveillance, registries, and traceability [ 30 , 32 , 33 , 78 , 79 ].…”

Section: Challenges With Multiple Switchingmentioning

confidence: 99%

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

Feagan

Marabani

et al. 2020

Adv Ther

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With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) evidence studies. However, as more biosimilars of the same originator enter the market, multiple switching events between originators and biosimilars is becoming a reality, despite limited evidence to support the efficacy and safety of such practice. Some countries have established guidelines, policies, or laws related to interchangeability and/or automatic substitution, whereas others have left these practices unregulated or controlled by other components of the healthcare system. Collectively, guidelines on single non-medical switching are often vague, with even less focus given to multiple non-medical switching, leaving this practice mostly unregulated. This narrative review will first discuss the current regulatory perspectives on non-medical switching and challenges associated with switching therapies, particularly with the availability of multiple biosimilars. We will then review the current evidence from RCTs and RW studies in the light of three different multiple-switch scenarios currently taking place in clinical practice: switching between an originator and a single biosimilar, switching between biosimilars of the same originator, and the clinical practice of switching back to the originator (i.e., switchbacks) after a failure of the initial non-medical switch to the analogous biosimilar.

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Section: Challenges With Multiple Switchingmentioning

confidence: 99%

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

Feagan

Marabani

et al. 2020

Adv Ther

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“…Although many countries in the Middle East do not have biosimilar guidelines, several countries, including Iran, Lebanon, and Saudi Arabia, have developed guidelines 42. The Iran National Regulatory Authority used the WHO biosimilar guidelines as a resource; however, the Iranian guidelines are not as strict.…”

Section: Methodsmentioning

confidence: 99%

“…According to the most recent information available, three biologic therapies that are used in rheumatology are approved in Iraq: the TNF inhibitors etanercept and infliximab, and the anti-CD20 monoclonal antibody, rituximab 48. Only the originator biologics are available; no biosimilars are approved in the country 16,42…”

Section: Methodsmentioning

confidence: 99%

Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq

Abdulateef

Gorial

Al-Sulaitti

et al. 2018

OARRR

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Biologic therapies are an important option in the treatment of patients with rheumatic disease. As the development of potential biosimilars increases, many countries are following the guidelines developed by the WHO, European Medicines Agency, or US Food and Drug Administration to create country-specific regulations for the review and approval of these products. Iraq does not yet have such regulations, and this presents a potential safety concern for patients. The analytical, nonclinical, and clinical data requirements for approval of a potential biosimilar are specific and scientifically rigorous. In some countries, products are available that have not met the stringent criteria for biosimilars; they are usually referred to as “intended copies”. Frequently, the available data are not sufficient to demonstrate that they are similar in efficacy and safety to the reference product. Thus, safety issues may arise once the product is in use, as was the case with Kikuzubam, an intended copy of rituximab that was withdrawn from the market in Mexico following reports of severe adverse reactions. It is important to implement scientific, evidence-based guidelines for the review, approval, therapeutic use, and monitoring of biosimilars, and to provide training on this topic to healthcare professionals and patients. In this review, we discuss issues related to the use and regulation of biosimilars, and the differences between biosimilars and intended copies. We also provide suggestions for including biosimilars as a treatment option in Iraq.

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“…In the USA, on average, 40% of RD patients receive biological treatment, in contrast to the Middle East and north Africa where coverage is only 2% [ 33 , 63 ]. The factors considered for this inequality may be associated with the difficult access of BP and with the difficulties in monitoring treatment with biologicals.…”

Section: Biopharmaceuticals In Rheumatic Diseasesmentioning

confidence: 99%

“…According to the FDA, in the Biologics Price Competition and Innovation Act (BPCIA) of 2009, manufacturers must supply sufficient information to indicate the biosimilarity of the biotherapeutic, including the same clinical result as the reference product in any patient. Equally, if there is a change from an innovator to a biosimilar, it must be demonstrated that the administration of the biosimilar will not affect the safety and efficacy of the innovator [ 63 , 65 , 66 ].…”

Section: Biopharmaceuticals In Rheumatic Diseasesmentioning

confidence: 99%

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

et al. 2020

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Since we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals.

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

Cited by 19 publications

References 39 publications

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

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