DEVELOPMENT OF BIOSIMILARS: AN OVERVIEW OF THE REGULATORY FRAMEWORK IN INDIA, USA, EU; MAJOR CHALLENGES AND RELATED CASE STUDIES

A similar biologic product also called biosimilar, follow-on biologic, is highly similar in terms of quality, safety, efficacy with that of the reference product. These are the pharmaceutical products used as the prime treatment options in many chronic diseases and as substitutes for the primary treatment. For development and approval, each nation has adopted its own regulations, and some countries are adopting WHO guidelines. In India Institutional BioSafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC), CDSCO are the competent authorities involved in the approval process. In EU the legal basis of Article 10(4) of Directive 2001/83/EC lays down the requirements for the Marketing Authorization Applications (MAAs) based on the demonstration of the similar nature of the two biological medicinal products. The US Biologics Price Competition and Innovation Act of 2009 (BPCIA) permits the licensing of biological products. During the development process, the biosimilar developer should consider specific parameters like the manufacturing process, demonstrating analytical similarity, which includes structural and functional similarity, interchangeability, and extrapolation of indications. In addition to these parameters, the other major hurdle for biosimilar development is the lack of harmonization of the regulations. This article covers an overview of the regulatory framework in India, USA, EU and the major challenges associated with biosimilars development with related case studies.