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An Empirical Analysis of the Perceived Challenges and Benefits of Introducing Biosimilars in Bangladesh: A Paradigm Shift

机译：对孟加拉国引进生物仿制药的感知挑战和收益的实证分析：范式转变

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摘要

The high demand for and resulting financial success of biopharmaceutical products over the last three decades have seen the door open for close copies of these biological products, also known as biosimilars. This paper seeks to collate all relevant published intelligence with acquired survey data to assess the weight of available evidence that these products hold immense potential for the pharmaceutical industry in terms of their applications and benefits. Biosimilars also pose to be of great promise to the Bangladesh pharmaceutical industry, with the commitment of drastically reducing its dependence on foreign imports of biopharmaceutics to meet local demand. Our questionnaire based survey involved 100 Clinicians, 50 Industry Experts and 100 Academicians. The study found that majority of Industry Experts (72%) and Academicians (63%) shared a different concept of biosimilars opposed to majority of Clinicians (78%). Majority of Academicians (68%) and Industry Experts (61%) also shared a different belief from that of most Clinicians (61%) regarding the need for updating the existing regulatory guidelines. The study also showed that Clinicians (67%), Industry Experts (83%) and Academicians (80%) highlighted the benefit of lower costs of biosimilars. Furthermore, the quality data obtained from the survey results allowed us to evaluate and provide recommendations for stakeholders on the need for increased biosimilar awareness, pharmacovigilance and safety in Bangladesh.
机译：在过去的三十年中，对生物制药产品的高需求以及由此带来的财务成功，已经为这些生物产品（也称为生物仿制药）的仿制复制打开了大门。本文力图将所有相关的已发表情报与获得的调查数据进行核对，以评估现有证据的权重，这些证据证明这些产品在制药行业的应用和益处方面具有巨大潜力。生物仿制药对孟加拉国制药业也具有巨大的希望，承诺将大大减少其对国外进口生物制药的依赖，以满足当地需求。我们基于问卷的调查涉及100位临床医生，50位行业专家和100位院士。研究发现，与大多数临床医生（78％）相对，大多数行业专家（72％）和院士（63％）分享了不同的生物仿制药概念。与大多数临床医生（61％）相比，大多数院士（68％）和行业专家（61％）对更新现有法规指南的需求也持有不同的看法。研究还显示，临床医生（67％），行业专家（83％）和院士（80％）强调了降低生物仿制药成本的好处。此外，从调查结果中获得的质量数据使我们能够评估孟加拉国对生物仿制药的认识，药物警戒性和安全性的需求，并向利益相关者提供建议。

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