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生物类似药在新兴市场的采用动态。

Dynamics of biosimilar uptake in emerging markets.

机构信息

Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.

The Hilltop Institute, University of Maryland Baltimore County, Baltimore, USA.

出版信息

Expert Opin Biol Ther. 2022 Jun;22(6):679-688. doi: 10.1080/14712598.2022.2076557. Epub 2022 May 22.

Abstract

INTRODUCTION

Globally, biosimilars are expected to play a key role in lowering healthcare costs and providing increased patient access to biological therapies. Given this, and in line with the European Union and World Health Organization, many emerging nations have adapted and established biosimilar regulatory guidelines. Emerging nations present a lucrative market for biosimilar development and commercialization, yet they also pose unique challenges. A thorough understanding of the unique attributes of emerging markets in relation to biosimilars is needed to promote their successful uptake in low- and middle-income countries.

AREAS COVERED

This article highlights the opportunities and challenges that emerging markets represent in terms of biosimilar uptake. A comprehensive analysis of biosimilar uptake in European countries, where biosimilars have gained significant market share, was carried out to identify policies that can enhance market penetration in emerging nations.

EXPERT OPINION

Implementation of pricing and procurement policies, as well as provider and patient confidence in biosimilar efficacy, are key factors in their uptake. Due to the high cost of biosimilar development, incentivizing domestic companies with the biosimilar manufacturing capability to produce these drugs will be helpful in ensuring a sustainable biosimilar market and a steady supply chain.

摘要

简介

在全球范围内,生物类似药有望在降低医疗成本和增加患者获得生物疗法方面发挥关键作用。有鉴于此,许多新兴国家已经根据欧盟和世界卫生组织的要求,制定并建立了生物类似药监管指南。新兴国家是生物类似药开发和商业化的有利可图的市场,但也带来了独特的挑战。为了促进生物类似药在中低收入国家的成功应用,需要深入了解新兴市场在生物类似药方面的独特属性。

涵盖领域

本文重点介绍了新兴市场在生物类似药应用方面所带来的机遇和挑战。对已在欧洲国家(生物类似药已获得显著市场份额)中应用的生物类似药进行了全面分析,以确定可提高新兴国家市场渗透率的政策。

专家意见

定价和采购政策的实施,以及提供者和患者对生物类似药疗效的信心,是其采用的关键因素。由于生物类似药开发成本高昂,通过激励具有生物类似药生产能力的国内公司生产这些药物,将有助于确保生物类似药市场的可持续性和稳定的供应链。

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