Brooklyn Journal of International Law


Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The true complexity of a biosimilar’s structure makes it much more difficult to create biosimilar regulatory pathways that can ensure the safety of consumers. The process for approving a biosimilar requires greater analysis and consideration than traditional generic drug approval. With the increase in the number of biosimilars available, the process of naming biosimilars has become an important regulatory concern; causing countries to develop various methods of naming approved biosimilars. Some regulatory bodies use the international nonproprietary name (INN) of the reference product. Others regulatory bodies in Australia and Japan attach a short and separate qualifier. In the United States, brand companies have proposed that the biosimilars should receive a unique INN. However, a lack of uniformity in nomenclature would result in the same biological medicine having different meanings in different areas of the world. In attempts to avoid the promulgation of separate and distinct national qualifier systems, several regulatory authorities have requested that the WHO’s INN Programme develop a universal nomenclature system applicable to biosimilars. Ultimately, this Note suggests that in order to successfully promote the growth of the biosimilars market and facilitate the true intent of global legislation creating abbreviated approval path-ways for biosimilars, the WHO, together with the EU and the United States, should ensure biosimilars are afforded INNs that are identical to their existing biologic counterpart.