Legal Pathways for Biosimilar: Comparison of Legal Rules in Different Countries

Abstract

The generics of biologic drugs play a significant role in pharmaceutics and therapeutics owing to their affordability to a
group of patients with fatal diseases. Even though the challenges in manufacturing of these drugs are overcome by
biosimilar applicants, the disputes on patents hamper the market entry of biosimilar. The countries such as United States,
European Union, Japan, Canada etc. follow divergent legal pathways to avoid these conflicts. In this article, the patent
dancing in US and patent linkage systems in various countries are elaborated. As for India, few generic manufacturers
attempted to resolve patent disputes through lawsuits, yet no patent linkage system is established by legislation.