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ESPGHAN: More Research Needed on Use of Biosimilars in Pediatric IBD
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Children with inflammatory bowel disease who are responding well to biologics should not be switched to biosimilars until more research data becomes available, according to an expert consensus statement from the European Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Biosimilars, “the counterpart of generics in terms of biologicals,” are coming to the market as the patents for anti-tumor necrosis factor (TNF) agents expire, which will result in at least a 30% reduction in the cost of anti-TNF drugs and increased access to treatment, according to the statement. Both the FDA and the European Medicines Agency (EMA) have decided that documentation of efficacy is not required for all indications of the original molecule for biosimilars; furthermore, the EMA has approved biosimilars for infliximab for all conditions, including pediatric IBD.
Lissy de Ridder
According to the ESPGHAN Pediatric IBD Porto Group that developed consensus recommendations for use of biosimilars in pediatric IBD, however, “extrapolation of the limited available clinical data from adults with rheumatologic diseases to children with [IBD] should be done with caution and needs some considerations.”
“Pediatric gastroenterologists are concerned about the introduction of biosimilars in pediatric inflammatory bowel disease,” Lissy de Ridder, MD, PhD, ESPGHAN Pediatric IBD Porto Group member from Erasmus Medical Center/Sophia Children’s Hospital in the Netherlands, told Healio Gastroenterology. “Children with IBD have more severe disease and potentially need anti-TNF treatment for a longer period than adult patients. Data on efficacy and safety of the use of anti-TNF biosimilars in this specific patient group are urgently needed.”
The consensus statements on which 83% of the 36 members of the pediatric IBD Porto group voted include:
- High priority should be given to long-term pediatric trials to support the EMA’s approval of biosimilars for infliximab for all indications including pediatric IBD.
- Pediatric IBD patients in sustained remission on a specific medication should not be switched to a biosimilar until safety and efficacy data from clinical trials in IBD become available.
- A mandatory requirement for marketing biologics and biosimilars should be post-marketing surveillance programs to confirm efficacy, safety and immunogenicity in pediatric IBD.
“Due to the absence of published trials on the usage of biosimilars in adult and pediatric IBD, [these statements] cannot be used as recommendations for management,” the authors wrote. “They reflect expert opinion designed to inform pediatric gastroenterologists and to promote consensus on proper usage of these agents in children with IBD.” – by Adam Leitenberger
Disclosure: de Ridder reports she has received consultation fees, research grants or honoraria from Shire, Merck, Janssen Biologics, AbbVie and Hospira. Please see the full statement for a list of all other authors’ relevant financial disclosures.
Perspective
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Marla C. Dubinsky, MD
The use of biosimilars in IBD, both for pediatric and adult patients, remains a hot topic for discussion. The European Medicines Agency has elected to approve biosimilars in IBD based on extrapolated safety and efficacy data from other disease indications. This has not been the case in North America. The concerns remain universal with the emphasis on the differences in afucosylation, which could affect the antibody-dependent cellular cytotoxicity effects of the molecule, and the possible differences in clearance and immunogenicity, all of which are critical for the use of biologics in IBD and speak to the importance of formal pharmacokinetic/pharmacodynamics studies in IBD patients prior to acceptance of extrapolation and part of a registration packet.
There is no doubt that lowering the costs associated with IBD therapy is appealing and much needed. However, in the absence of the required data mentioned above and an adequately powered comparative effectiveness trial it is hard to imagine the widespread acceptance of the use of a biosimilar as a substitute for a biopharmaceutical. This would be particularly so in the case of non-medical switching. Taking an IBD patient who is doing well on a biopharmaceutical and mandating they switch to a biosimilar for cost or third party-mandated reasons does not resonate well.
There is much work to be done to fully grasp the breadth of these emerging and very real clinical scenarios. Investigators, advocacy groups, industry and regulatory agencies must all be on the same page to advocate for patients with lifelong progressive diseases such as IBD and ensure they can have confidence in all approved therapies.
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