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Varied approach to interchangeability across the MENA region

Home/Reports | Posted 22/11/2019

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).

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Designing fit-for-purpose biosimilar studies

Home/Reports | Posted 15/11/2019

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].

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Uptake of biosimilars in different countries varies

Home/Reports | Posted 08/11/2019

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

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Biosimilar regulation in the Middle East

Home/Reports | Posted 08/11/2019

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.

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Considerations for real-world research on biosimilars

Home/Reports | Posted 08/11/2019

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:

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Impact of biologicals on health care

Home/Reports | Posted 25/10/2019

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.

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Challenges for European pharmacovigilance

Home/Reports | Posted 06/09/2019

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.

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Achieving consistent regulation for biosimilars

Home/Reports | Posted 26/07/2019

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.

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Challenges facing the US biosimilars market

Home/Reports | Posted 19/07/2019

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).

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Factors contributing to long-term sustainability of biosimilars

Home/Reports | Posted 31/05/2019

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

Home/Reports | Posted 24/05/2019

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].

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Challenges for biosimilar sustainability in Europe

Home/Reports | Posted 10/05/2019

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.

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WHO says more communication and education needed to increase access to biosimilars

Home/Reports | Posted 03/05/2019

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.

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WHO prequalification for rituximab and trastuzumab: first results

Home/Reports | Posted 26/04/2019

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.

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WHO Global Benchmarking Tool Revision VI includes ‘Listed Authorities’

Home/Reports | Posted 19/04/2019

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.

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WHO releases Q&A on biosimilars evaluation

Home/Reports | Posted 12/04/2019

At the 17th Biosimilar Medicines Conference in The Netherlands, the World Health Organization (WHO) outlined a new Q&A document to assist with the regulatory evaluation of biosimilar products.

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Biosimilar clinical trials as confirmatory evidence

Home/Reports | Posted 05/04/2019

During her presentation at the European Commission’s Multi-Stakeholder Conference, which was held in Brussels, Belgium on 14 September 2018, Dr Elena Wolff-Holz discussed the importance of carrying out clinical trials with biosimilars [1].

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Use of biosimilars in oncology in Europe

Home/Reports | Posted 01/04/2019

Dr Elena Wolff-Holz gave a presentation at the European Commission’s Multi-Stakeholder Conference, which was held in Brussels, Belgium on 14 September 2018 giving an overview of biosimilars approved in Europe to date [1].

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Changing attitudes for biosimilars in gastroenterology

Home/Reports | Posted 22/03/2019

Professor Tibor Hlavatý, from United European Gastroenterology, which is a European umbrella organisation for gastroenterologists, gave a presentation on the current position of biosimilars in the field of gastroenterology at the fourth European Commission Stakeholder Conference on Biosimilar Medicines, which was held on 14 September 2018 in Brussels, Belgium [1].

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Gulf countries discuss global harmonization of biosimilars

Home/Reports | Posted 15/03/2019

The regulation, approval and use of biosimilars is subject to global debate. Policies and regulations differ from country to country which can lead to confusion over biosimilars integrity. To ensure increased uptake and affordability of biosimilars, their safety and reliability needs to be assured. Worldwide, governments must adapt regulatory procedures to facilitate biosimilar market access and low prices.