药物警戒杂志

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Biosimilars: Regulatory Status and Implications across the World

Rajesh Kumar, Sandra Sigala, Renato Bertini Malgarini, Giuseppe Pimpinella, Luca Pani, Sergio Pecorelli and Maurizio Memo

Biological drugs, also known as first generation biopharmaceuticals, are being produced for the last 30 years and are in clinical use for a number of diseases. Recently, the expiry of many of these product patents led to the development of other non-innovator similar biologics at lower costs, having the same safety, purity and potency as their original counterparts. These non-innovator similar biologics are generally referred to as biosimilars.

Biosimilars are produced in living organisms by recombinant DNA techniques and exploiting the cellular mechanisms of the host so, there could be some differences at the molecular level due to their complex nature. Henceforth, they have to face numerous challenges for their development and approval, including the complex manufacturing process, immunogenicity issues, nomenclature, extrapolation of different indications, interchangeability with their originators, awareness amongst the clinicians and patients and the costs of production for the manufacturers.

As these molecules are designed to mimic human proteins, they can give rise to serious efficacy and safety concerns, indeed the standard generic approach is not applicable to demonstrate similarity between a biosimilar and its reference product. So, many Regulatory Authorities have established guidelines for the development and approval of biosimilars.

Biosimilars are an essential product category that makes biological drugs available to different markets at an affordable cost. Their use is ought to increase in the upcoming years as per the demand and supply of these drugs is concerned. Hence, aim of this review is to discuss the problems surrounding the biosimilars and to give an overview on their regulatory statuses across the world. Concluding, we believe that to achieve a balance between drug quality, safety and the population health needs, a profound knowledge of biosimilar development as well as joint effort of the manufacturers and their will to share the critical development data, is needed.