Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview

Sharma, Atul; Khante, Shyam; Mahadik, Kakasaheb R.; Gaikwad, Vinod L.

doi:10.1007/s43441-020-00112-8

Cited by 3 publications

(2 citation statements)

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“…Establishing a comparable safety profile for a specific indication is crucial at this stage before extrapolating safety data. Immunogenicity data, being a specific criterion, require thorough substantiation and add complexity to the process [ 1 , 35 ].…”

Section: Development Of Biosimilar Medicinesmentioning

confidence: 99%

“…Regarding the Middle East market, the emergence of biosimilar medicines has allowed such medicines to reach other countries characterised by a high percentage of poverty, avoiding the poor-quality imitations that are so typical of these regions [ 35 ]. The Central Drugs Standard Control Organisation is the organisation responsible for medicines in India, and its mission is to ensure that all procedures are reliably controlled.…”

Section: Regulatory Framework For the Development Of Biosimilarsmentioning

confidence: 99%

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A Regulatory Perspective on Biosimilar Medicines

Cordeiro,

Vitorino,

Sinogas

et al. 2024

Pharmaceutics

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By definition, biosimilar medicinal products are biological medicinal products that are similar to other biological medicinal products that are already on the market—the reference medicinal products. Access to biosimilar medicines is a current reality. However, to achieve this goal, it is extremely important to consistently and scientifically substantiate the regulatory requirements necessary for biosimilar medicines when accessing the market. Based on an analysis of the raw materials and the type of methods used in the manufacturing processes of biological medicines, it is known that this tends to be more complex for the quality of the finished product than the manufacture of molecules obtained through a chemical process. It is then relevant to highlight the main differences between both products: biological medicines manufactured using biotechnology and the current generics containing active pharmaceutical ingredients (APIs) obtained from synthetic processes. Once arriving at the approval process of these medicinal products, it is imperative to analyse the guidance documents and the regulatory framework that create the rules that allow these biosimilar medicinal products to come to the market. The present review aimed at documenting comparatively the specific provisions of European legislation, through the European Medicines Agency (EMA), as well as the legislation of the United States of America, through the Food and Drug Administration (FDA). This was then translated into a critical appraisal of what concerns the specific criteria that determine the favourable evaluation of a biosimilar when an application for marketing authorisation is submitted to different regulatory agencies. The gathered evidence suggests that the key to the success of biosimilar medicines lies in a more rigorous and universal regulation as well as a greater knowledge, acceptance, and awareness of health professionals to enable more patients to be treated with biological strategies at an earlier stage of the disease and with more affordable medicines, ensuring always the safety and efficacy of those medicines.

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Section: Development Of Biosimilar Medicinesmentioning

confidence: 99%

Section: Regulatory Framework For the Development Of Biosimilarsmentioning

confidence: 99%

A Regulatory Perspective on Biosimilar Medicines

Cordeiro,

Vitorino,

Sinogas

et al. 2024

Pharmaceutics

View full text Add to dashboard Cite

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

Mirjalili

Sabourian

Sadeghalvad

et al. 2021

International Immunopharmacology

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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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Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview

Cited by 3 publications

References 0 publications

A Regulatory Perspective on Biosimilar Medicines

A Regulatory Perspective on Biosimilar Medicines

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

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

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