Hypersensitivity reaction to a biosimilar insulin glargine 对甘精胰岛素生物仿制品的过敏反应
摘要
It is considered that allergy to human recombinant insulin is an uncommon condition, occurring in no more than 1% of insulin users.1 To the best of our knowledge, allergy to insulin analogs is also rare, with no more than a few case reports in the scientific literature.2-4 In fact, some desensitization strategies have been proposed by using insulin analogs like glargine in cases of allergy to recombinant regular insulin.4-6 Biopharmaceuticals are drugs containing biotechnology substances (proteins or polysaccharides) as their active ingredients, most of them developed with recombinant DNA techniques, and therefore, are produced in living systems.7 Patents of several biopharmaceuticals have recently expired, or are due to expire.8 This has provided opportunities for pharmaceutical companies to produce biosimilars or “follow-on biologics”. These products are intended to come at lower costs with a comparable clinical effect. However, sometimes these drugs differ from conventional generic drugs in several ways, including the size of the active substance, its complexity, and the very nature of the manufacturing process.7-9 Major differences in the manufacturing process that relate with suboptimal clinical outcomes mean that biosimilars should not be approved and regulated in the same way as conventional generic drugs, since a high probability of substandard copies reaching the market arise when biocomparability is established with traditional PK assays.7 Therefore, regulatory authorities around the world are attempting to establish different approval pathways for biosimilars.10 In some countries it has been a common feature that biosimilars are not associated with the same pharmacovigilance strategies and risks management plans that follow biologic innovators.10 Hence, a substandard biosimilar has the potential of causing adverse reactions and unpredictable clinical effects that are usually underreported. Here we report the first case of hypersensitivity reaction to a bi