ECCO position challenged by European drug regulators

Dear Sir, Danese and Gomollon issued an ECCO position statement on the use of similar biological medicinal products (biosimilars) in inflammatory bowel disease (IBD)1, arguing that the use of biosimilars in patients with IBD will require clinical trials in this particular patient population, with comparison to the innovator product. The authors state that subtle differences in structure may lead to profound differences in immunogenicity and efficacy, even with the same biological medicine. Indeed, when changes are introduced in the manufacturing process of any biological product, its new version is not identical, and therefore, manufacturers must demonstrate that safety and efficacy remain unchanged. From a regulatory standpoint, the same principle applies to the development of biosimilars; the innovator and biosimilar products contain two versions of the same active substance, which need to be shown highly similar through an extensive comparability programme, including confirmatory clinical studies. The authors also state that a biosimilar proven effective and safe for one indication may not necessarily be so for another indication of the innovator product. Therefore, the onus is on the manufacturer to justify that pharmacokinetic, efficacy and safety data collected in one therapeutic indication may be extrapolated to other indications based on the overall evidence of comparability. The reliability of this regulatory approach is supported by the extensive European experience, which to date has allowed patient access to safe and efficacious biosimilars with the same therapeutic indications as the innovators.