The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to variations in biosimilar uptake across countries, and even within countries, as was investigated for tumour necrosis factor-alfa (TNF-α) inhibitor biosimilars in Sweden [1, 2]. In Germany, biosimilar market shares are also known to vary at the regional level. This was studied by Blankart et al. for erythropoiesis-stimulating substances, filgrastim and somatropin, and variations in biosimilar market shares were partly attributed to the presence of explicit regional cost-control measures, such as quota regulations . Differences in the uptake of biosimilars have also been described in Germany for the class of TNF-α inhibitors, although reasons behind this variable uptake have not been examined in detail .
Rational medicines use (RMU) is the prescribing/dispensing of good quality medicines to meet individual patient’s clinical needs. Policymakers, managers and frontline providers play critical roles in safeguarding medicine usage thus ensuring their rational use. Therefore, in order to investigate this, researchers carried out a study investigating the perspectives of key health system actors on prescribing practices and factors influencing these in Eswatini, South Africa . Public sector healthcare service delivery in the region is carried out through health facilities (public sector, not-for-profit faith-based, industrial) and community-based care.
Celltrion completed the acquisition of selected primary care assets from Takeda Pharmaceutical Company Limited in the Asia Pacific region in November 2020. In addition, the company announced it will be building a new biopharmaceutical plant and a global biotechnology research centre in Songdo, Incheon, South Korea.
The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 . Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.