BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists

Abstract

Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn's disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…133 There was much debate on the issue of approval for extrapolated IBD indications. 39,134 Therefore, real-world experience with CT-P13 used in IBD has been of particular interest to gastroenterologists. The significant body of post-authorization data published has not revealed any unexpected concerns in this population, 135 validating the regulatory decision to grant approval in the extrapolated indications.…”

THERAPIES FOR CROHN'S DISEASE: a clinical update

“…This new topic in the biologics era remains to be better elucidated. Biosimilar results and safety for CD will be demonstrated as this drug begins to be used more widely in this specific group of patients (52) . More recently, another class of biological drugs known as anti-integrin antibodies has been introduced into clinical practice.…”

Anvisa Approves the First Biosimilar Monoclonal Antibody Based on Comparability in Brazil

“…CT-P13 is produced by a South Korean pharmaceutical company and will be marketed and distributed in Brazil by a partnership between two American companies (1,18,19) . CT-P13 is a biosimilar medication to Infliximab (IFX), which uses the original product, manufactured in the United States as the reference drug (1,2,3,6,18,19) . This measure by ANVISA is primarily aimed at cost reduction, because most of the individuals currently using IFX can only do it due to reimbursement by the Brazilian public health system.…”

“…However, scientific, safety and pharmacovigilance issues have arisen and should be carefully addressed and widely discussed within this new scenario for the benefit of patients. CT-P13 has been approved in Brazil based on comparability strictly following the regulations of ANVISA (1,18,19) . The original IFX was approved in Brazil in 2000 for the treatment of luminal Crohn´s disease.…”

“…This drug is also approved in our country in other indications: rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, fistulizing Crohn's disease and ulcerative colitis. In accordance with the European Agency (EMA -European Medicine Agency), ANVISA also follows strict international standards for the approval of biosimilar agents (1,2,3,6,9,18,19) . As mentioned, CT-P13 has been approved by ANVISA based on comparability.…”