Lorant Gonczi, Akos Ilias, Zsuzsanna Kurti and Peter L. Lakatos* Pages 13 - 18 ( 6 )
The introduction of biological drugs has revolutionized the management of inflammatory bowel diseases (IBD), however, the increasing financial burden of biologicals on the health care system is alarming. Biosimilars are considered to be equivalent to the reference medicinal product (RMP) in terms of pharmacokinetic properties, clinical effectiveness and safety. CT-P13 infliximab was the first biosimilar to be approved by the regulatory authorities EMA and US FDA, and others are becoming increasingly available as patents expire on the RMP. Emerging data suggests that one-way switching from the RMP to an approved biosimilar is safe and acceptable, however data on multiple-switching, reversed switching, or cross-switching between biosimilars is scarce. Accumulating data on biosimilars led to an increased acceptance amongst physicians and their use can be expected to offer increased availability for patients, and also better control of economic sustainability. This review discusses the available data on clinical efficacy and safety of approved biosimilar agents, and assesses the current impact and future perspectives of biosimilars on the health care system.
Crohn's disease, ulcerative colitis, biosimilars, infliximab, switch, cost-effectiveness.
First Department of Internal Medicine, Semmelweis University, Budapest, First Department of Internal Medicine, Semmelweis University, Budapest, First Department of Internal Medicine, Semmelweis University, Budapest, First Department of Internal Medicine, Semmelweis University, Budapest