Background/Aims Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the ada...

Abstract Background and scope: The current situation in Iran suggests a good basis for advancement in biotechnology industries because the patents for many hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies without patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present researc...

Abstract Background and scope: The current situation in Iran suggests a good basis for advancement in biotechnology industries because the patents for many hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies without patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present researc...

This application note describes how the Agilent Bio-Monolith Protein A column was applied to the optimization of Chinese hamster ovary cell-culture conditions to produce a recombinant monoclonal antibody with desired structural characteristics, focusing on glycosylation. The workflow demonstrates the versatility and wide applicability of the column in biopharmaceutical and biosimilar development.

Introduction The biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC). Aim To assess the efficacy and safety of the biosimilar product Inflectra®...

The manuscript by Flodmark et al. [1] recently published in the open-access journal Biologics in Therapy describes a single-center experience in Sweden of a switch from an originator biologic to a biosimilar human growth hormone (rhGH) using a dialogue teamwork approach [1]. Unfortunately, the authors fail to mention several limitations to their study which call into question their conclusions....

PURPOSE Granulocyte colony-stimulating factors (G-CSFs), filgrastim and lenograstim, are recognised to be useful in accelerating engraftment after autologous stem cell transplantation. Several forms of biosimilar non-glycosylated G-CSF have been approved by the European Medicines Agency, with limited published data supporting the clinical equivalence in peripheral blood stem cell mobilisation a...