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How to support a viable US biosimilars market

In a previous article Ms Juliana Reed, President of the Biosimilars Forum, outlined why the US biosimilars market is sluggish at the DIA Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA [1].

The sluggish US biosimilars market

Juliana Reed, President of the Biosimilars Forum, gave a presentation on ‘The State of the Biosimilars Market’ at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23-24 September 2019 in Bethesda, Maryland, USA [1].

Varied approach to interchangeability across the MENA region

To achieve global agreement on issues of regulatory approval of biosimilars, open discussion across national borders and between different stakeholder groups is key. A lack of agreement between countries that make up the Middle East and North Africa (MENA) region, particularly in the area of interchangeability and switching, was made clear at a meeting organized by the Generics and Biosimilars Initiative (GaBI).

Designing fit-for-purpose biosimilar studies

The design of biosimilar studies that are fit for purpose was discussed by Dr Jaclyn Bosco of IQVIA through the presentation on ‘Biosimilar considerations for real world research and stakeholder questions’ [1].

Uptake of biosimilars in different countries varies

The uptake of biosimilars in different countries was a subject discussed by both Dr Jaclyn Bosco and Mr Murray Aitken of IQVIA.

Biosimilar regulation in the Middle East

The Generics and Biosimilars Initiative’s second Middle East and North Africa (MENA) Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars [1] opened with an introduction to United Arab Emirates’ (UAE) National Strategy for Innovation.

Considerations for real-world research on biosimilars

In a presentation on ‘Biosimilar Considerations for Real World Research and Stakeholder Questions’ at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA, considerations for real-world research on biosimilars were discussed by Dr Jaclyn Bosco of IQVIA. These include:

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.