© Springer International Publishing AG 2018 261
A.S. Cheifetz, J.D. Feuerstein (eds.), Treatment of Inflammatory
Bowel Disease with Biologics, https://doi.org/10.1007/978-3-319-60276-9_15
Chapter 15
Biosimilars in Inflammatory Bowel Disease
2017: State of the Science, State of the Art,
and State of the Finances
Christina Y. Ha and Asher Kornbluth
Abbreviations
ADA Anti-drug antibodies
aNDA Abbreviated new drug applications
AS Ankylosing spondylitis
AUC Area under serum concentration
BPCI Biologics Price and Control Act
CAG Canadian Association of Gastroenterology
CCFA Crohn’s and Colitis Foundation of America
CD Crohn’s disease
CI Confidence interval
ECCO European Crohn’s and Colitis Organization
ECL Electrochemiluminescent immunoassay
EMA European Medicines Agency
FDA Food and Drug Administration
IBD Inflammatory bowel disease
PD Pharmacodynamic
PK Pharmacokinetic
RA Rheumatoid arthritis
C.Y. Ha
Center for Inflammatory Bowel Diseases, David Geffen School of Medicine at UCLA,
Los Angeles, CA 90095, USA
A. Kornbluth (*)
Henry Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai,
1150 Fifth Ave, Suite 1B, New York, NY 10128, USA
e-mail: [email protected]