Reports
Impact of biologicals on health care
In a presentation entitled ‘Biosimilar Considerations for Real World Research and Stakeholder Questions’ delivered at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA, Dr Jaclyn Bosco of IQVIA discussed the impact that biologicals have had on health care.
Challenges for European pharmacovigilance
The European Union (EU) pharmacovigilance system is one of the most advanced worldwide, but challenges remain for the system. Dr Sabine Straus, Chair of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) outlined the strengths and weaknesses of the system, and discussed what the future holds for European pharmaco-vigilance, at the 12th Pharmacovigilance Conference in January 2019.
Achieving consistent regulation for biosimilars
Although biosimilars offer the similar clinical outcome as their reference counterparts at a lower price, this is yet to be fully recognised in the US. Regulatory consistency is essential to achieving a successful biosimilars market in the US, according to Dr Gillian Woolett of healthcare consultancy Avalere Health, who gave a presentation focused around the biosimilars market in the US at the 17th Biosimilar Medicines Conference in The Netherlands.
Challenges facing the US biosimilars market
At the 17th Biosimilar Medicines Conference in The Netherlands, Dr Gillian Woolett of US healthcare consultancy Avalere Health discussed challenges facing the biosimilars market in the US and upcoming changes in the Food and Drug Administration (FDA).
Factors contributing to long-term sustainability of biosimilars
The factors that may contribute to the long-term sustainability of the biosimilars market in Europe were presented by Murray Aitken of the IQVIA Institute for Human Data Science at the 17th Biosimilar Medicines Conference.
The level of biosimilars competition in Europe varies
Patient use of biologicals has generally increased following the introduction of biosimilars. Despite this, levels of competition in Europe are variable across molecules and countries, see Table 1, Murray Aitken explained at the 17th Biosimilar Medicines Conference [1].
Challenges for biosimilar sustainability in Europe
At the 17th Biosimilar Medicines Conference, Executive Director of the IQVIA Institute for Human Data Science (formerly the IMS Institute), Murray Aitken, outlined the challenges facing biosimilars in terms of long-term sustainability in Europe.
WHO says more communication and education needed to increase access to biosimilars
The World Health Organization (WHO) has emphasized the importance of communication, trust and education in order to increase patient access to biosimilars in high-income countries. The issues were discussed by Emer Cooke, Head of the Regulation of Medicines and other Health Technologies Department, at the 17th Biosimilar Medicines Conference.
WHO prequalification for rituximab and trastuzumab: first results
At the 17th Biosimilar Medicines Conference, the World Health Organization (WHO) outlined the first results for their pilot project for the prequalification of two cancer drug biosimilars.
WHO Global Benchmarking Tool Revision VI includes ‘Listed Authorities’
To help countries to build effective regulatory systems, the latest World Health Organization (WHO) Global Benchmarking Tool includes a shift towards ‘WHO-listed authorities’ (WLAs), replacing the previous ‘Stringent Regulatory Authorities’ (SRAs). The full procedure for listing as a WLA will be developed based on a broad consultation process.
