The approval of biosimilars in the EU follows a comprehensive scientific assessment based
on stringent regulatory standards. While the initial approach to biosimilars was …

Over time, clinicians have become increasingly comfortable embracing the prescription of
biosimilars—highly similar versions of innovator or reference biological agents—for their …

Biosimilar use is limited in some healthcare systems because biosimilars are not well
understood by many healthcare professionals and patients. The knowledge gap is …

Highlights•Licensing of biosimilars promotes wider patient access to essential
medicines.•Currently, regulators require comparative efficacy trials for complex …

Highlights•There are different regulatory approaches toward interchanging
biosimilars.•Blinded clinical studies do not reflect switching in clinical practice.•Current data …

Biosimilar monoclonal antibodies (mAbs) have been approved in the European Union since
2013 and have been demonstrated to reduce healthcare costs and to expand patient …

Background: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-
modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that …

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized
medicines. Compared with small-molecule drugs, biological drugs are more complex, more …

Background Current knowledge is limited about which manufacturers are active in the global
field of biopharmaceutical product development and how many unique follow-on biologics …

Background Although there is increasing support for biosimilar medicines by the Iraqi
Ministry of Health (MOH), there is scarce information about whether physicians accept these …