Advanced Techniques in Biology & Medicine
Open Access
ISSN: 2379-1764
ISSN: 2379-1764
Magda Constantin
Romania
Review Article
Biosimilars: A Review of Published Randomized Control Trials Comparing Biosimilars with their Reference Products
Author(s): Rodica Olteanu, Magda Constantin and Alexandra ZotaRodica Olteanu, Magda Constantin and Alexandra Zota
Biosimilars represent a therapeutic revolution for many immune-mediated inflammatory diseases. Biosimilars have different regulatory requirements than those of originators. These regulatory requirements are based on the evidence generated from bioequivalence studies, and in particular from RCTs. The goal of our review was to search for published randomized control trials that investigate biosimilars compared to their reference medicine (infliximab, adalimumab, etanercept, ustekinumab) in chronic inflammatory diseases (psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative cholitis, by using the Medline (PubMed) databases. Nineteen randomized control trials investigating biosimilars compared to their reference drug were included. As of November 2017, five anti-TNF biosimilar agents have been granted approval and are available on .. View More»
DOI:
10.4172/2379-1764.1000252