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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.

Spanish pharmacists publish biosimilar position statement

The Spanish Society of Hospital Pharmacy (Sociedad Española de Farmacia Hospitalaria, SEFH) has published a position statement on the use of biosimilars [1]. The statement expresses the position of the society on the strategies to be followed concerning the processes of selecting, evaluating and implementing these types of medicines in the healthcare setting.

WHO considers cost of cancer drugs and how to increase access

The increasing prices of cancer drugs is ‘impairing the capacity of healthcare systems to provide affordable, population-wide access to cancer medicines’, according to a report issued by the World Health Organization (WHO).

International promotion and education for biosimilars

International initiatives to promote the use of biosimilars and improve their understanding is just one of the subjects investigated by a report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) [1].

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