Abstract
The aim of this paper is to shed light on the controversial topic of biosimilars, biogenerics and bioequivalence with regard to recombinant DNA (rDNA) products. This phenomenon has garnered extensive press and yet is very much in its infancy. Although the terms ‘biosimilar’ and ‘biogeneric’ are basically interchangeable for purposes of argument, here, the term ‘biosimilar’ will be used. What is a biosimilar? In its broadest definition a biosimilar is an rDNA molecule/biopharmaceutical that is comparable to the originator's molecule. Biopharmaceuticals are drugs derived from living organisms. These substances are quite complex and are therefore more difficult to manufacture consistently, characterise, quantify, purify and copy. What happens if the molecule cannot be classified as biosimilar? In most cases it will then be classified as a new entity in and of itself. Herein lies the paradox that many originators/innovators use to increase barriers to entry that competitive manufacturers must overcome.
In terms of barriers to entry, it must be stated that patents often pose a worthy obstacle for many firms to overcome. Patents or intellectual property (IP) are very specific deterrents for competitors to manoeuvre around and are a worthwhile defence mechanism for originators to have in their arsenal. Additionally, regulatory guidance, or the lack thereof, is a key variable for firms to consider; they must weigh the pros and cons prior, during and after such considerations are made to decide whether to invest major resources within this new venture, and how those sacrifices will or will not pay off.
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