British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

CA Lamb, NA Kennedy, T Raine, PA Hendy, PJ Smith… - Gut, 2019 - gut.bmj.com
Ulcerative colitis and Crohn's disease are the principal forms of inflammatory bowel disease.
Both represent chronic inflammation of the gastrointestinal tract, which displays …

[HTML][HTML] Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes

HP Cohen, A Blauvelt, RM Rifkin, S Danese… - Drugs, 2018 - Springer
Methods A systematic search was conducted using the Medline® and Embase® databases
up to 30 June 2017 employing specific medical subject heading terms. Additionally, the …

To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 …

B Glintborg, AG Loft, E Omerovic… - Annals of the …, 2019 - ard.bmj.com
Objectives Real-world evidence on effectiveness of switching to biosimila r etanercept is
scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) …

Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: a regulatory perspective

P Kurki, S Barry, I Bourges, P Tsantili, E Wolff-Holz - Drugs, 2021 - Springer
Background Biosimilars have been used for 15 years in the European Union (EU), and have
been shown to reduce costs and increase access to important biological medicines. In spite …

Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches

A Blauvelt, JP Lacour, JF Fowler Jr… - British Journal of …, 2018 - academic.oup.com
Background Adalimumab is used to treat several inflammatory diseases, including plaque
psoriasis. GP2017 is a proposed adalimumab biosimilar. Objectives To assess the impact of …

Switching from reference adalimumab to SB5 (Adalimumab Biosimilar) in patients with rheumatoid arthritis: Fifty‐Two–Week Phase III randomized study results

ME Weinblatt, A Baranauskaite… - Arthritis & …, 2018 - Wiley Online Library
Objective The 24‐week equivalent efficacy and comparable safety results of the biosimilar
SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with …

Etanercept for the treatment of rheumatoid arthritis

S Zhao, E Mysler, RJ Moots - Immunotherapy, 2018 - Taylor & Francis
Etanercept was the first specific anticytokine therapy approved for the treatment of
rheumatoid arthritis (RA). Its clinical efficacy and safety has been demonstrated by several …

Nonmedical switching from originators to biosimilars: does the nocebo effect explain treatment failures and adverse events in rheumatology and gastroenterology?

R Fleischmann, V Jairath, E Mysler, D Nicholls… - Rheumatology and …, 2020 - Springer
The act of nonmedical switching, defined as switching stable patients who are generally
doing well with their current therapy from an originator biologic to its biosimilar, has been …

Era of biosimilars in rheumatology: reshaping the healthcare environment

JS Smolen, J Goncalves, M Quinn, F Benedetti… - RMD open, 2019 - rmdopen.bmj.com
Compared with the original approved biological drug on which it is based, a biosimilar has
highly similar physicochemical characteristics and biological activity, as well as equivalent …

Regulatory evaluation of biosimilars: refinement of principles based on the scientific evidence and clinical experience

P Kurki, HN Kang, N Ekman, I Knezevic, M Weise… - BioDrugs, 2022 - Springer
Abstract The World Health Organization (WHO) guidelines on evaluation of similar
biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert …