Pharmaceutical Industry Reports biosimilar pipeline analysis market | Page 2

REPORT DESCRIPTION
Biosimilar Pipeline Analysis Market – Overview
Biosimilar is a type of biological product that is almost identical to the original product, which has undergone
patent expiration. Development and validation of biosimilars are an important part of the overall production
process. Regulation for biosimilar drugs plays an important role in maintaining the efficiency and balance
between original and biosimilar drugs. There are various authorities such as U.S. Food and Drug Administration
(FDA) and European Medicines Agency (EMA), which regulate the development and commercialization of
biosimilars. Biosimilar drugs are available at relatively low prices as compared to patented drugs without
compromising on efficacy.
Biosimilar has a complex structure, multi-layer manufacturing and immunogenicity risk due to which they require
unique regulatory pathways for introduction in the market. Biosimilar ensures treatment of diseases considered to
be incurable such as cancer and autoimmune disorders, they are developed independently and have same
mechanism of action as patented drugs for the specific disease. There are different stages involved in the
development of biosimilars such as product development, process development, clinical trial and regulatory
approval and review.