Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders

Mirjalili, Seyedeh Zohreh; Sabourian, Reyhaneh; Sadeghalvad, Mona; Rezaei, Nima

doi:10.1016/j.intimp.2021.108305

Cited by 3 publications

(3 citation statements)

References 53 publications

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“…Over time, drug development has tried to compensate, through targeted approaches, for any deficiencies observed in certain diseases or disorders. More than two decades ago, biological medicines were introduced on the market [ 6 ]. They are produced from living cells, using biotechnology techniques, unlike common medicines, which are produced from chemical synthesis in the laboratory [ 7 , 8 , 9 ].…”

Section: Biological Medicinesmentioning

confidence: 99%

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An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

Mascarenhas-Melo,

Diaz,

Gonçalves

et al. 2024

Pharmaceuticals

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Biological therapies have transformed high-burden treatments. As the patent and exclusivity period for biological medicines draws to a close, there is a possibility for the development and authorization of biosimilars. These products boast comparable levels of safety, quality, and effectiveness to their precursor reference products. Biosimilars, although similar to reference products, are not identical copies and should not be considered generic substitutes for the original. Their development and evaluation involve a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations and clinical trials. Clinical studies conducted for biosimilars aim to establish similar efficacy, safety, and immunogenicity, rather than demonstrating a clinical benefit, as with the reference product. However, although the current knowledge regarding biosimilars has significantly increased, several controversies and misconceptions still exist regarding their immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The development of biosimilars stimulates market competition, contributes toward healthcare sustainability, and allows for greater patient access. However, maximizing the benefits of biosimilars requires cooperation between regulators and developers to ensure that patients can benefit quickly from access to these new therapeutic alternatives while maintaining high standards of quality, safety, and efficacy. Recognizing the inherent complexities of comprehending biosimilars fully, it is essential to focus on realistic approaches, such as fostering open communication between healthcare providers and patients, encouraging informed decision-making, and minimizing risks. This review addresses the regulatory and manufacturing requirements for biosimilars and provides clinicians with relevant insights for informed prescribing.

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Section: Biological Medicinesmentioning

confidence: 99%

“…They are produced from living cells, using biotechnology techniques, unlike common medicines, which are produced from chemical synthesis in the laboratory [ 7 , 8 , 9 ]. As previously mentioned, biological medicines play a critical role in the treatment of various diseases [ 6 , 9 ].…”

Section: Biological Medicinesmentioning

confidence: 99%

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

Mascarenhas-Melo,

Diaz,

Gonçalves

et al. 2024

Pharmaceuticals

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“…The main advantage of mAb over most small molecule drugs is that it has a larger surface area for binding and therefore has excellent specificity, which reduces "off-target" effects. However, mAbs are expensive compared to abiotic therapies and, like all drugs, have their own risks [2].…”

Section: Introductionmentioning

confidence: 99%

The Application and Mechanism of Monoclonal Antibodies in Diseases

Cao

2024

HSET

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Monoclonal antibodies (mAbs), as a kind of highly specific biological drugs, play an increasingly important role in the treatment and prevention of diseases. Monoclonal antibodies were invented in the 1970s and went through four stages of development to become fully humanized antibodies. The principle is to use cell fusion technology to fuse myeloma cells and B lymphocytes, and then use HAT culture medium to screen successfully fused hybridoma cells. The preparation process of mAbs is varied, and the required biotechnology (protein purification, ELISA, immunofluorescence) and equipment are complex. With the continuous progress of biotechnology, mAb has been widely used in many fields such as tumor, autoimmune disease and infectious disease. At present, there are many mAb drugs on the market for the treatment of various intractable diseases. In tumor therapy, mAbs can inhibit the growth and spread of tumor cells by targeting tumor cell surface antigens, and improve the therapeutic effect. In autoimmune diseases, mAb can target autoantigens, regulate the immune response, reduce symptoms, and improve the condition. In addition, mAbs also play an important role in the treatment of infectious diseases, such as neutralizing viruses, bacteria and other pathogens, preventing their infection of cells. The mechanism of mAbs, including binding to antigens, triggering signal transduction, endocytosis and degradation, and inducing immune response, is also introduced. There are also many binding sites where mAbs act on different diseases, such as PD-1, PD-L1, CD20, F and G surface proteins of RSV. MAb has excellent specificity and effectiveness, but it is expensive and has its own risks. With the continuous development and optimization of monoclonal antibody technology, its application prospect in the future disease treatment will be broader.

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Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA

Amaral,

Rodrigues,

Veiga

et al. 2024

Applied Sciences

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Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biological medicine that is used as its reference. These medicines go through less clinical studies than their reference product and therefore the cost of their development process is significantly lower, giving patients access to them more quickly and at a more affordable price. However, due to the structural complexity and inherent degree of variability of these products, it is very difficult to develop biosimilar medicines that are exactly the same as the reference product. Thus, it is extremely important to define strict controls to guarantee that these minor differences are not clinically significant in terms of safety and efficacy. Like any other medicine, biosimilars have to go through a complex approval process, which involves a thorough assessment by regulatory authorities to ensure these products meet the necessary standards of quality, safety, and efficacy before being placed on the market. Due to their nature and complexity, the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

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Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders

Cited by 3 publications

References 53 publications

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

The Application and Mechanism of Monoclonal Antibodies in Diseases

Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA

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