Current market and regulatory landscape of biosimilars Journal Article


Author: Bhatt, V.
Article Title: Current market and regulatory landscape of biosimilars
Abstract: The introduction of biologic therapies has improved the treatment landscape for multiple diseases, particularly in the areas of oncology, rheumatology, and endocrinology. Although they are effective, biologics are associated with increased costs that result in economic burden for healthcare professionals and patients. Biosimilars are biologic medical products that are almost an identical copy of the original product. There are differences in the regulatory requirements for the original biologic product and a biosimilar, as biosimilars gain FDA approval through an abbreviated approval pathway. The incorporation of these products into the US market will potentially result in improved patient access and decreased healthcare costs. There are barriers, such as lack of familiarity, that affect the use of biosimilars. Strategies to overcome these barriers are essential to improve the uptake of these products in the United States.
Journal Title: American Journal of Managed Care
Volume: 24
Issue: 21
ISSN: 1088-0224
Publisher: Intellisphere, LLC  
Date Published: 2018-11-01
Start Page: S451
End Page: S456
Language: English
PUBMED: 30452213
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 3 December 2018 -- Source: Scopus
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MSK Authors
  1. Valkal Bhatt
    61 Bhatt
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