Emerging Trends in Biologics and Biosimilars

Emerging Trends in Biologics and Biosimilars

Author Name : Chavan Rutuja, Kolhe Vishakha ,Kiran Shinde, Snehal Bhand, Bhushan Khajindar, Vishal Tekude

ABSTRACT Emerging Trends in Biologics and Biosimilars Biologics, large therapeutic molecules derived from living organisms, have transformed treatment approaches for diseases such as cancer, autoimmune disorders, and diabetes. However, their high costs limit accessibility for many patients. Biosimilars, biologics with no clinically meaningful differences in safety, purity, or efficacy from their reference products, present a cost-effective alternative, increasing access to life-saving treatments. The global biosimilar market has grown significantly since the approval of the first biosimilar in Europe in 2006. India has emerged as a key player in this field, approving its first biosimilar for hepatitis B in 2000 and establishing robust regulatory guidelines to support the development, manufacturing, and marketing of biosimilars. Indian pharmaceutical companies have gained international recognition, with several obtaining U.S. FDA approval for their biosimilars, particularly in cancer care. Biosimilars like filgrastim, trastuzumab, and bevacizumab are widely used to enhance supportive cancer therapy, reducing costs and expanding treatment access. Despite challenges such as concerns over immunogenicity and interchangeability, biosimilars continue to show promise for improving healthcare outcomes globally. India's thriving biosimilar ecosystem, supported by its regulatory advancements and manufacturing capabilities, positions the country as a potential leader in the global market. The sector is expected to grow rapidly, offering substantial economic opportunities and improving patient care through more affordable biologic therapies.