Biological medicines contain a biological substance that is produced by or derived from a
living organism. The active substances of biologicals are usually larger and more complex …

Biopharmaceuticals are complex molecules produced by living cells. Copies of these drugs,
called biosimilars, are not identical to their reference medicine, and therefore specific …

As many biological products face losing their patents in the next decade, the pharmaceutical
industry needs an abbreviated regulatory pathway for approval of biosimilar drug products …

Background Only drafts of regulatory guidelines for the registration of biosimilars are
available in Lebanon. We analyzed the results of a regional survey conducted in Lebanon to …

Biological (large molecule) drug products are made via living systems and are complex and
variable in nature. As a result, generic forms of biological products, also termed biosimilars …

Abstract The European Union (EU) has instituted internal and external measures aimed at
protecting and enforcing intellectual property rights. In the area of pharmaceutical patents …

随着生物药专利失效期到来所带来的成本降低, 药物可及性增加及巨大市场空间等因素影响,
各大企业对生物仿制药的开发表现出浓厚的兴趣, 纷纷涉足这一领域, 然而由于生物仿制药的 …

本文通过文献综述, 在明确界定生物类似物概念的基础上, 阐述了生物药的特点及其研发生产
过程. 基于欧盟版生物类似物指南, 介绍了其政策框架, 并系统梳理了生物类似物政策监管指南 …

目的: 按照药物临床安全性和警戒性的要求, 对生物仿制药的生物利用度, 临床疗效安全性进行
评价, 以制订生物仿制药警戒计划. 方法: 对我国生物仿制药在前期研究, 临床试验 …

Объективная оценка взаимозаменяемости лекарственных препаратов является
актуальной проблемой во всем мире, так как способствует снижению затрат при …