ABSTRACT
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.
ABSTRACT
A 40-year old woman with recent asymmetric arthritis and fever was evaluated in our clinic. NSAIDs were recommended, but a few days later she was admitted to our hospital because of worsening arthritis along with the appearance of new skin lesions in both feet. Although she was treated with antibiotics and high dosages of steroids, her arthritis did not improve. The skin lesions progressed from bullous initially to ulcerative pyoderma gangrenosum, so we suggested endoscopic examination of the colon which revealed Crohn's disease. The patient received I.V. treatment with infliximab resulting in a remarkable response. Some patients with Crohn's disease may present with extraintestinal manifestations well before the bowel disease is manifested and diagnosed.
