Ghosh Prasanta Kumar
Managing Partner, Sompradip Publishers and Consultants, Block C2B, Flat 5A, Janakpuri, New Delhi, India.
J Pharm Pharm Sci. 2017 Oct-Dec;19(4):552-596. doi: 10.18433/J34K6B.
The invention and use of a large number of biologics during the last three decades for treating various deficiencies and chronic disorders has resulted in great benefit to human health. Abundant use of these biologics has been considerably constrained due to the reasons of their increased prices, charged by the inventors up to the time up to which their use were/are protected by intellectual property rights (IPR).Some of these biologics are presently being manufactured by the existing and newer companies as "similar biologics" after the IPR on these products have expired and as a result the prices of several such medicines are coming down."Similar biologics" are also referred to as "biosimilars" and other related names in different parts of the world. The regulatory authorities of different countries have authorized use of "similar biologics" based on comparative evaluation of each of such medicines with the inventor's biologics; these are approved when considered to be closely similar to the inventor's biologics in properties, quality and efficacy. By 2020, a dozen of "inventor's biologicals" having estimated market sale-value of over USD 79 billion are going out of protection of IPR. This would drive entrepreneurs to enter in to the field and the prices are going to crash considerably due to market competition. In course of time more "biosimilars" would go out of IPR. Different proactive governments and the regulatory agencies all over the world are trying to harness the existing and future opportunities by creating regulatory guidelines to ease faster authorization for use of "similar biologics" in their territories. Up to the present time, a small number of "similar biologics" have been approved for use in different countries all over the major parts of the world. More efficient technologies for manufacture of "similar biologics" are also getting developed. Together, these efforts are anticipated to ease the availability of "similar biologics" at more affordable prices to the users/ payers the world over. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.
在过去三十年中，大量生物制品被发明并用于治疗各种缺陷和慢性疾病，给人类健康带来了巨大益处。由于发明者在其知识产权保护期内提高了这些生物制品的价格，其大量使用受到了相当大的限制。目前，其中一些生物制品在相关产品的知识产权到期后，已由现有和新成立的公司作为“类似生物制品”进行生产，因此，几种此类药物的价格正在下降。“类似生物制品”在世界不同地区也被称为“生物类似药”及其他相关名称。不同国家的监管机构已根据对每种此类药物与发明者生物制品的比较评估，批准使用“类似生物制品”；当这些药物在性质、质量和疗效方面被认为与发明者的生物制品非常相似时，它们就会被批准。到2020年，估计市场销售额超过790亿美元的十几种“发明者生物制品”将失去知识产权保护。这将促使企业家进入该领域，由于市场竞争，价格将大幅下跌。随着时间的推移，更多的“生物类似药”将失去知识产权保护。世界各地积极主动的政府和监管机构都在努力利用现有和未来的机会，制定监管指南，以便在其领土内更快地批准使用“类似生物制品”。到目前为止，世界主要地区的不同国家已批准少量“类似生物制品”投入使用。制造 “类似生物制品” 的更高效技术也在不断发展。这些努力共同预期将以更实惠的价格，向全球用户/付款人提供 “类似生物制品”。本文接受发表后审查。注册读者（见“读者须知”）可通过点击本期目录页面上的摘要进行评论。
