Tocilizumab (TCZ), is a recombinant humanized anti-interleukin-6 receptor (IL-6R)
monoclonal antibody which has a main use in the treatment of rheumatoid arthritis, systemic …

The collection and assessment of individual case safety reports (ICSRs) is important to
detect unknown adverse drug reactions particularly in the first decade after approval of new …

In recent years, marketing of highly innovative and costly biologics improved the
management of high-burden diseases such as autoimmune diseases, cancers, and chronic …

Increasing numbers of biosimilar medicines are becoming available. The objective of this
survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical …

In the USA, an interchangeability designation provides biosimilar sponsors with a pathway
for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution …

Abstract “Non-biological complex drugs”(NBCDs), such as liposomal formulations, iron-
carbohydrate complexes and glatiramoids, gained increased interest from a regulatory …

Introduction The under-reporting of adverse drug events (ADEs) is an international health
concern. A number of studies have assessed the root causes but, to our knowledge, little …

Biosimilars are copies of reference biological drugs, developed as the patents for original
biologicals expire. They are thus developed to replicate an original biological medicine just …

Cannabis is increasingly accepted by medical organizations for medicinal and research
purposes. A traceability system is required for monitoring and controlling the use of …

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