PBI55 FUTURE TRENDS ON THE BIOSIMILAR UPTAKE IN THE EU5 AND THE US

Abstract

Biosimilar use creates an opportunity for increased patient access, drug competition and cost-savings, especially in a landscape driven by imminent patent-expiration of biologics. Study aimed to assess anticipated trends and incentives to enhance biosimilar uptake in the United States (US) and Europe’s big 5 (EU5: France, Germany, Italy, Spain, the United Kingdom). Targeted literature review was conducted in Medline/Embase, complemented with desk research. Differences in supply- and demand-side policies for biosimilars are impacting global market uptake. Successive policy shifts are seen following collection of biosimilar switching evidence and continuous debate to support further penetration of biosimilars to generate more economic savings. In France, biosimilar use became a part of the health strategy (2018-2022), aiming to achieve 80% of biosimilar penetration in 2022. Although automatic substitution was introduced by law in France (2014), it is still not implemented due to the lack of a published decree. In Germany, a bill allowing biosimilar substitution by pharmacists awaits for the legislative approval since 2018; due to criticism and revisions, implementation of this reform will be postponed by 3 years. Meanwhile, G-BA was mandated to introduce a list of interchangeable biosimilars to support physician-authorised switching. In Spain and the UK, hospital pharmacy stocking of a one preferred drug over tendering for multiple products is expected. Real-world evidence for Italy shows the increasing trend for biosimilar use with great variability among regions. Despite infancy in the US biosimilar uptake, the FDA released the Biosimilars Action Plan (2018) outlining 11 key actions to boost the biosimilar industry and facilitate access, with a guideline for demonstrating interchangeability (2019). Even though market share of biosimilars remains low, with except to some drug-tendering processes, regulations are evolving rapidly and a number of tools should be implemented in the near future to boost the biosimilar uptake in the following years.