Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist
The management of inflammatory bowel disease (IBD), a significant cause of morbidity in the United States (US), has been revolutionized over the last two decades by the introduction of biologic therapies. These include antitumor necrosis factor α (TNF-α) agents. Since 2016, five biosimilar TNF-α inh...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2018-09-01
|
| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/1756284818799600 |
| _version_ | 1818035424841433088 |
|---|---|
| author | Michael Epstein |
| author_facet | Michael Epstein |
| author_sort | Michael Epstein |
| collection | DOAJ |
| description | The management of inflammatory bowel disease (IBD), a significant cause of morbidity in the United States (US), has been revolutionized over the last two decades by the introduction of biologic therapies. These include antitumor necrosis factor α (TNF-α) agents. Since 2016, five biosimilar TNF-α inhibitors have been approved by the US Food and Drug Administration (FDA) for use in the treatment of IBD. The FDA has published a series of guidance documents related to the evaluation, licensing, and approval of biosimilars. The aim of this review is to provide an overview of these FDA guidances and the issues associated with biosimilars in the US. |
| first_indexed | 2024-12-10T06:54:50Z |
| format | Article |
| id | doaj.art-1f9aa4337847470ca60991e31513240d |
| institution | Directory Open Access Journal |
| issn | 1756-2848 |
| language | English |
| last_indexed | 2024-12-10T06:54:50Z |
| publishDate | 2018-09-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-1f9aa4337847470ca60991e31513240d2022-12-22T01:58:28ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482018-09-011110.1177/1756284818799600Food and Drug Administration guidances on biosimilars: an update for the gastroenterologistMichael EpsteinThe management of inflammatory bowel disease (IBD), a significant cause of morbidity in the United States (US), has been revolutionized over the last two decades by the introduction of biologic therapies. These include antitumor necrosis factor α (TNF-α) agents. Since 2016, five biosimilar TNF-α inhibitors have been approved by the US Food and Drug Administration (FDA) for use in the treatment of IBD. The FDA has published a series of guidance documents related to the evaluation, licensing, and approval of biosimilars. The aim of this review is to provide an overview of these FDA guidances and the issues associated with biosimilars in the US.https://doi.org/10.1177/1756284818799600 |
| spellingShingle | Michael Epstein Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist Therapeutic Advances in Gastroenterology |
| title | Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist |
| title_full | Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist |
| title_fullStr | Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist |
| title_full_unstemmed | Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist |
| title_short | Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist |
| title_sort | food and drug administration guidances on biosimilars an update for the gastroenterologist |
| url | https://doi.org/10.1177/1756284818799600 |
| work_keys_str_mv | AT michaelepstein foodanddrugadministrationguidancesonbiosimilarsanupdateforthegastroenterologist |