Children suffering from inflammatory bowel disease (IBD) who are reacting positively to prescribed biological medications should not have their prescriptions changed to recently approved “biosimilar” products, according to the results of an expert consensus statement issued by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). These conclusions were published by Wolters Kluwer in the Journal of Pediatric Gastroenterology and Nutrition, which is the official journal of the European Society of Pediatric Gatroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Biosimilars, which are therapies that are developed to function similarly to that of biological medicines, could decrease medical costs and increase access to effective biological medications at the same time, however, more studies are required to confirm their effectiveness and safety in children with IBD, according to the ESPGHAN Pediatric IBD Porto Group.
To address Crohn’s disease and ulcerative colitis, anti-TNF therapies are often prescribed to patients with childhood-onset IBD due to their ability to quickly heal their intestine.
Anti-TNF medicines are biological protein-based drugs that are quite complex and their formulations are kept secret by the pharmaceutical companies that produce them. Because of this, biosimilars are not exactly equal to their biological counterparts, despite being similar to the original products in their mechanism of action.
When the anti-TNF medicines’ patents expire, biosimilar products will remain available to patients, decreasing the costs of therapies in the healthcare marketplace. To date, some biosimilars have already been approved, while others were denied approval.
The Porto Group experts warn that with biosimilars, even minor alterations in the production process might lead to changes in cell behavior, which could lead to differences in a treatment’s safety, efficacy and immunogenicity [causing an allergic reaction to the drug]. Immunogenicity in children is more severe and dangerous than in adults, which is why the ESPGHAN Pediatric IBD Porto Group is raising these concerns.
Until more results are available, it is recommended that children who have responded well to a specific biologic agent should not be switched to biosimilars. Surveillance programs and post-marketing assessments are crucial, according to the researchers, in order to monitor effectiveness and safety issues with biosimilars that might occur.
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