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Biosimilars – An Introduction

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Rheumatoid arthritis (RA), the most common autoimmune disease, has traditionally been treated with disease modifying anti-rheumatic drugs (DMARDs). But in the last 15 years or so, the introduction of biological response modifiers has revolutionized the treatment of RA. Among these, anti-tumor necrosis factor (TNF) agents were the first to be successfully used in treating RA.

Unlike traditional pharmaceuticals, biologic drugs are derived from living organisms. Recombinant DNA biotechnology has allowed large-scale production based on master cell banks from different sources. Many biologic drugs are used in internal medicine, for example insulin, growth hormone, erythropoietin, IFN-α and monoclonal antibodies. In the past decade, rheumatology has been transformed with the introduction of monoclonal antibodies directed against cytokines involved in the pathogenesis of inflammatory arthritis, such as RA, AS and autoimmune diseases associated with arthritis such as psoriasis and IBD.

Biosimilars – the inside story

In recent times, the development of biosimilars or follow-on biologicals and the introduction of biological therapeutics for treatment of rheumatic diseases has significantly improved patient outcomes. With some of these ‘reference (originator) products’ approaching patent expiration, manufacturers are developing follow-on versions. Biosimilars may improve access to expensive biological agents; however, concerns have been raised regarding their clinical use. In particular, due to the complexities of manufacturing ‘copies’ of biological therapeutics, physicians have questioned whether biosimilars will confer identical biological function, efficacy and toxicity to reference products, both in the short and long term. These concerns are not without substantiation, since even minor modifications in manufacturing processes, which iteratively occur with reference products, may alter biological functions and/or immunogenicity, potentially changing their safety and efficacy profile.

Regulations on biosimilars vary from country to country and are put through stringent review and validation. But the fact remains that biosimilars are here to stay, for effective treatment of rheumatoid arthritis.

For Rheumatologists

Rheumatologists should be concerned not only for safety and efficacy, but also for other issues such as immunogenicity of the biosimilar product and well-designed comparative trials. In the case of traditional chemical compounds, synthesis is initiated from commercially available substrates; this is not the case with biologic compounds.

Rheumatologists also need to be aware of two things in their respective countries.

  • First, the biosimilar product can only really be classified as a biosimilar copy or an intended copy with proper head-to-head trials against the innovator. This information will most likely influence a rheumatologist’s prescription towards a branded product in favour of a biosimilar unless the reimbursement in their respective country affects the status of the originator brand.
  • Second, although in emerging markets the advent of biosimilars may reduce the high cost of biologic therapies for the patient, the practicing rheumatologist should be aware of the proper development of a biosimilar, as it may have been licensed using relaxed standards and may not be a truly bioequivalent biosimilar .

While the bioequivalence of generic drugs is well established, a completely different kind of assessment is required, including laboratory testing to prevent production and clinical evaluation pitfalls when dealing with large biologic products, complex molecules and extensive glycosylation. Importantly, before prescribing a biosimilar, rheumatologists should be aware of whether the similarity between the intended copy and the innovator or originator is met and of the fundamental challenges that are required to be labelled a truly biosimilar product.

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This web site is run by an Arthritis Specialist based in Dubai, United Arab Emirates. On this site you will find news about the latest in arthritis, information about research results in the field, tips and information and diet and exercise, and much more.

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This web site is run by an Arthritis Specialist based in Dubai, United Arab Emirates. On this site you will find news about the latest in arthritis, information about research results in the field, tips and information and diet and exercise, and much more.

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