[HTML][HTML] Biosimilars for the treatment of inflammatory bowel disease

VA Rudrapatna, F Velayos - Practical gastroenterology, 2019 - ncbi.nlm.nih.gov
VA Rudrapatna, F Velayos
Practical gastroenterology, 2019ncbi.nlm.nih.gov
Biosimilars are biologic products that are highly similar to a previously approved reference
(or originator) biologic drug in terms of safety, purity, and potency (efficacy). These
medications are increasingly being approved by global regulatory agencies in the hopes of
reducing treatment costs. To date, six biosimilars in the United States have been approved
for the treatment of inflammatory bowel disease (IBD). Despite their approval by regulatory
bodies and several years-worth of 'real world'evidence supporting their use, this class of …
Abstract
Biosimilars are biologic products that are highly similar to a previously approved reference (or originator) biologic drug in terms of safety, purity, and potency (efficacy). These medications are increasingly being approved by global regulatory agencies in the hopes of reducing treatment costs. To date, six biosimilars in the United States have been approved for the treatment of inflammatory bowel disease (IBD). Despite their approval by regulatory bodies and several years-worth of ‘real world’evidence supporting their use, this class of medications remain somewhat unfamiliar to many clinicians and patients. This review aims to answer common questions regarding biosimilars and their use for IBD. It is written in a question/answer format for easy reference and guides the reader from the basics of biosimilars, to clinically relevant questions encountered in the clinic, to their policy implications, among other topics.
ncbi.nlm.nih.gov