Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus.

As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians' current knowledge, beliefs, practical approaches, and concerns related to biosimilar adoption-whether initiating a biosimilar, transitioning from an originator to a biosimilar, or switching between biosimilars (including multiple switches and reverse switching)-a global survey was conducted. Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. This consensus centered on 10 key statements covering biosimilar effectiveness, safety, indications, rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching, and future perspectives. Ultimately, the consensus affirmed that biosimilars are equally effective and safe when compared to originator drugs. They are considered suitable for both biologic-naïve patients and those who have previously been treated with originator drugs, with cost reduction being the primary motivation for transitioning from an originator drug to a biosimilar.

From Basic Immunology to Clinical Practice: Bio-Originators versus Bio-Similars.

Biologic agents are macromolecules, and as such, they have a high level of structural heterogeneity. Treatment with such agents has been extremely expensive limiting thus their availability to increasing numbers of patients; therefore, many manufacturers chose to develop biologics that are highly similar to the originators, the biosimilars. The immunological properties of both products should therefore be characterized and compared. The biosimilar developers must have a complete qualitative documentation, appropriate preclinical pharmacodynamic and pharmacokinetic studies, and finally comparative studies with the originator to define the relative similarity in terms of biologic activity, quality characteristics, efficacy and safety. Immunogenicity assessment of the biosimilars continues through clinical trials and pharmacovigilance programs.