Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy.

Potential of Chickpea Flours with Different Microstructures as Multifunctional Ingredient in an Instant Soup Application.

Chickpea flours are an interesting multifunctional ingredient for different food products. This study investigated the potential of differently processed chickpea flours as alternative thickening agents in an instant soup recipe, replacing potato starch. Dry instant soup powders were compared on bulk density and powder flowability, whereas prepared liquid instant soups were studied in terms of rheological behaviour (as influenced by microstructure) and volatile composition.

Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

Background: A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics.

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches.

The European Union's Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these.