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首页> 外文期刊>The regulatory affairs journal: Pharma >Regulatory Focus: Preparing for Biosimilars
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Regulatory Focus: Preparing for Biosimilars

机译:监管重点:生物仿制药的准备

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The official European name for these therapies is similar biological medicinal products. However many people refer to them by the shortened term, biosimilars. In the US, the products are sometimes called follow-on protein products. More often they go by the name, follow-on biologies. All of these terms refer to a new category of medicinal product that could soon become part of medical care in the developed world. Biosimilar products are not simply generic copies of small molecule drugs. Rather, they are similar versions of originator products containing recombinant DNA-derived proteins. But like generics, they are not protected by patents. This means that once they come onto the market, they should be priced competitively and help lower the cost of medical care in many countries.
机译:这些疗法在欧洲的正式名称是类似的生物医药产品。但是,许多人用简称“生物仿制药”来称呼它们。在美国,这些产品有时称为后续蛋白质产品。它们更常被称为后续生物学。所有这些术语都指的是一类新的医药产品,在不久的将来可能会成为医疗保健的一部分。生物仿制药产品不仅是小分子药物的通用复制品。相反,它们是包含重组DNA衍生蛋白的原始产品的相似版本。但是,与仿制药一样,它们不受专利保护。这意味着,一旦它们进入市场,它们就应该具有竞争力的价格,并有助于降低许多国家的医疗费用。

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