Experts from the steering committees of the Argentinian Society of Gastroenterology (SAGE), the Argentinian Federation of Gastroenterology (FAGE) and the Argentinian Group of Crohn's Disease and Ulcerative Colitis (GADECCU) have issued a joint position regarding the practical conditions for the clinical use of biosimilars indicated for inflammatory bowel diseases (IBDs), by discussing the most notable aspects related to the definition of a biosimilar drug, bio-similarity, non-comparable biological drugs or ‘intended copies’, approval requirements, extrapolation of indications, interchangeability, automatic substitution, non-medical switching, nomenclature, clinical standards regarding safety and efficacy, implementation of an efficient and appropriate pharmacovigilance system and the potential economic impact on the healthcare system .
Under the current research and development model, the pharmaceutical industry has switched its focus towards the therapeutic areas that offer the greatest commercial benefit, which are often not aligned with public health needs. Consequently, it has ceased to be the great innovative industry that it had been during the last century.
The passage in 1984 of the Hatch-Waxman Act set into motion sweeping changes to the US brand-name and generic drug competitive environment. It greatly increased generic drug competition for small-molecule drugs, by establishing a new abbreviated new drug application (ANDA) generic drug approval process that substantially reduced the time and cost associated with a generic drug marketing application submitted to the US Food and Drug Administration (FDA). In addition, it created incentives for challenges to brand-name drug patents, while also creating incentives for continued medical innovation and new drug development by drug innovators.
The US has experienced a policy debate as to whether competition from biosimilars is the best strategy for achieving price reductions for biologicals or, rather, whether direct price regulation after loss of patent exclusivity would be more effective. In order to investigate this issue, authors from the US and France combined quantitative and case study methods to examine in detail the interaction between market and administrative mechanisms to reduce biologicals’ prices in France. In their article they present comprehensive data on market shares and prices for three major biologicals and their 11 competing biosimilars between 2004 and 2020 .