Deana Ferreri, PhD
Articles
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimilar's FDA approval.
Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Originator in IBD
Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
Stable Patient Satisfaction Found After Switching From Humira or Biosimilar Adalimumab to CT-P17
A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
Faster Drug Approvals, Weaker Data? Study Raises Questions About FDA Process
Special approval programs have increased FDA administrative costs (paid for mostly by user fees), and postponements of generic competition have been costly to the US healthcare system, according to a recent article in JAMA.
