Volume: 5, Issue: 1
ABSTRACT
This paper explores the realm of biosimilars and how they are transforming the pharmaceutical sector. Unlike generic pharmaceuticals, biosimilars are biologic therapies that are designed to closely mimic authorized reference biologics. This paper attempts to clarify the development and history of biologics, as well as the advantages and difficulties of biosimilars through a thorough examination. The biologic market is now more competitive because of the emergence of biosimilars, which have improved patient access to necessary therapies and reduced costs. Treatment flexibility provided by interchangeability may increase therapeutic adherence. With the production of several biosimilars, India's biopharmaceutical sector has become a powerful force. India's emphasis on biosimilars is in line with the worldwide trend toward affordable biological medicines, even if issues like standardizing legislation, ensuring quality, and encouraging innovation still exist.
Biosimilar, Generic drug, Harmonizing regulations


