OBJECTIVES : 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 trends and incentives to enhance biosimilar uptake in China, Japan, the United States (US), EU4 (France, Germany, Italy, Spain) and the United Kingdom.

METHODS : Targeted literature review was conducted in Medline/Embase, complemented with desk research.

RESULTS : Chinese biosimilar market is evolving with 3 approved drugs since 2019, even though copy-biologics, not meeting the criteria for biosimilars, have been available in China for some time. An increase in the market growth is expected mainly due to more biosimilars in the pipeline than in any other country, yet being still worse regulated compared to EU, US and Japan. Biosimilar market in Japan is accelerating, influenced by unique payment system providing hospitals with a strong incentive to prescribe biosimilars. Also, the update of biosimilars guideline is anticipated for 2020. In France, biosimilar use became a part of the health strategy (2018-2022), the automatic substitution is still not implemented due to lack of published decree. Germany may implement automatic pharmacist level biosimilar substitution, however, due to uncertainty on the bill, it still awaits approval. 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 region variability. In the US, the FDA released the Biosimilars Action Plan (2018) to boost biosimilar industry and facilitate access, with a guideline for demonstrating interchangeability (2019).

CONCLUSIONS : Even though the market share of biosimilars remains low, various countries around the globe have implemented strategies to embrace the market and provide drugs to patients. Regulations are evolving rapidly and boost in the biosimilar uptake is expected in the following years, especially in China.