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Insights of biosimilars through SWOT analysis

机译:通过SWOT分析洞察生物仿制药

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摘要

Biological drugs, derived from living organisms, have immensely helped millions of patients across the globe. Biosimilars, although are the copies of the existing innovator biological products, cannot be substituted like the generic drugs owing to several differences. The final products in case of biosimilars are not identical as they are prepared from different cell lines by using different production methodologies and purification processes. Due to these differences, several challenges exist for entering into the biosimilar market. Many regulatory guidelines are now available for the approval of biosimilars. This renders an opportunity for healthcare community and industries to develop biosimilars in order to provide cost-effective treatment to the patients suffering from serious and life-threatening disorders. Despite the fact that entry of any biosimilar into the market would offer a competitive price advantage, large controversy exists regarding merits and demerits of biosimilars. In the present Editorial, we have carried out strength, weakness, opportunities and threats analysis of biosimilars so as to assist the readers in having a better understanding with broader perspective of biosimilars.
机译:源自生物体的生物药物极大地帮助了全球数百万患者。生物仿制药虽然是现有创新生物产品的复制品,但由于存在多种差异,因此无法像仿制药一样被替代。如果使用生物仿制药,最终产品是不同的,因为它们是通过使用不同的生产方法和纯化工艺从不同的细胞系制备的。由于这些差异,进入生物仿制药市场存在若干挑战。现在有许多监管指南可用于批准生物仿制药。这为医疗界和工业界提供了开发生物仿制药的机会,以便为遭受严重威胁生命的疾病的患者提供经济有效的治疗方法。尽管任何一种生物仿制药进入市场都将提供具有竞争力的价格优势,但在生物仿制药的优缺点方面仍存在大量争议。在本社论中,我们对生物仿制药进行了优势,劣势,机会和威胁分析,以帮助读者从更广阔的角度看待生物仿制药。

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