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Biosimilars market and opportunities in Europe

How the biosimilars market in Europe has changed and what opportunities for biosimilars exist for the near term in the region is being reviewed by Murray Aitken in this article [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.

WHO releases Q&A on biosimilars evaluation

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.

Biosimilar clinical trials as confirmatory evidence

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].

Use of biosimilars in oncology in Europe

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].

Changing attitudes for biosimilars in gastroenterology

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].

Gulf countries discuss global harmonization of biosimilars

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.