Biosimilars in paediatric inflammatory bowel disease

Abstract

The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conventional immunosuppressive and/or steroid therapy. The increasing occurrence of severe disease at diagnosis has resulted in infliximab being more often introduced as the first-line treatment in a “top-down” approach. Besides their favourable efficacy and safety profile, biologicals have one significant disadvantage, which is their high cost. This results in many patients stopping therapy prematurely, with the maintenance phase being too short. This often leads to disease exacerbation shortly after treatment cessation. Every newly started course of biological therapy can induce production of anti-drug antibodies, which can result in treatment failure and possible allergic/anaphylactic reactions. The introduction of biological biosimilars was intended to greatly reduce therapy costs thus increasing the availability of these agents to more patients. It was also anticipated that biosimilars would prevent premature termination of therapy. Analyses of paediatric data suggest that biosimilar infliximabs are equally effective as the reference infliximab. Safety patterns also seem to be similar. Paediatric experience places cost-therapy reductions at around 10%-30%.

Physicians’ Knowledge and Awareness about Biosimilars in Saudi Arabia: What is Imperative to Know ??

“…On the other side, a few healthcare organizations (HCOs) believed that biosimilars were complex proteins and could never be identical similar of the therapeutics agents. 2,[7][8][9] Despite such conflicts, biosimilars are used in numerous European countries and are getting approved in the United States and the rest of the world. 1,2 Cost-effectiveness, prescription patterns, dispensing practices and patients' belief about efficacy and safety of biosimilars are among the vital factors which are expressively essential to understand.…”

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

“…The first biosimilar used in Europe contained somatropin [recombinant human growth hormone (rhGH)] [ 5 ]. These new medicines have now become a big part of biological therapies used by many specialists in the treatment of rheumatoid arthritis, cancer, Crohn’s diseases, colitis, diabetes mellitus, osteoporosis, anaemia, immunologic diseases and other ailments, both in adults and in children [ 6 – 8 ]. At the time of writing (2018), 15 originator biological drugs had corresponding centrally authorised biosimilar medicines, which have been approved for therapy by the EMA (47 products), including adalimumab, bevacizumab, enoxaparin sodium, epoetin alfa, epoetin zeta, etanercept, filgrastim, follitropin alfa, infliximab, insulin glargine, insulin lispro, pegfilgrastim, rituximab, somatropin, teriparatide and trastuzumab [ 9 , 10 ].…”

Evaluation of the drug utilization of biosimilar medicinal products containing monoclonal antibodies: A systematic review

“…After conducting a number of in-depth analyses, the authors concluded that switching to biosimilar infliximab was the perfect solution to reduce treatment costs by 10-30% without compromising patient treatment. 18 Sarosiek T. and Morawski P. draw attention to the improved patient access to adequate therapy after the introduction of biosimilar medicinal products, in particular trastuzumab, and also identify reductions in treatment costs due to increasing competition. 19 Kim J. et al estimate the cost savings between 2011 and 2014 as a result of the use of biosimilar infliximab on the South Korean market.…”