Similar Biologics: Global Opportunities and Issues

Abstract

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.