One of the challenges posed to regulators will be the naming requirements for biosimilars. In order for physicians to select the most appropriate biosimilar medicinal product and also for pharmacovigilance purposes, the question has been asked as to what proprietary and/or non-proprietary name should be permitted for use on biosimilar products.
Biopharmaceuticals constitute a significant proportion of medicinal products used for the treatment of several life-threatening and chronic diseases. Moreover, biopharmaceutical drugs are one of the fastest growing segments of the pharmaceutical industry. The biopharmaceutical market, presently estimated at approximately US$200 billion globally is further projected to reach approximately US$500 billion by 2020.
It is estimated that over 400 biopharmaceuticals are currently in clinical trials for over 200 diseases, some of which currently do not have treatments. However, the development and manufacture of biologic medicines is very costly, resulting in a high price tag for treatment involving biopharmaceuticals. Healthcare expenditure can be decreased by using cheaper biosimilars (also variously referred to as similar biological medicinal products, similar biotherapeutic products, follow-on biologics, subsequent entry biologics, similar biologics), which are similar versions of already registered biological medicines.