On Monday 13 November, the Biotech industry will call on the WHO to address the naming (1) of biologicals including biosimilar medicines in the interests of patients and public health at the upcoming meeting for stakeholders organised by the WHO in Geneva (November 13, 2006).
EuropaBio welcomes this opportunity by the WHO and the international community to discuss and debate the issues related to the naming of biologicals and biosimilar medicines. This is necessary to ensure that with the arrival of biosimilar medicines, the traceability, substitution and pharmacovigilance of biosimilar and biological products are harmonised and guaranteed throughout all regions of the world.
Biosimilar medicines are truly unique products, not generics or identical copies of innovative biological products. EuropaBio supports the initiative that physicians and healthcare professionals are provided with specific information following the EMEA guidelines about biosimilar medicines in order to make an informed decision regarding their use. In addition, EuropaBio suggests that it is essential for each biosimilar medicine to have its own specific/original label.
"At EuropaBio, we are committed to working closely with the WHO. It is the best placed institution to work towards a fully international traceability system that can operate in the best interests of all parties: patients, regulators and manufacturers," said Johan Vanhemelrijck, Secretary General, EuropaBio - the EU association for bioindustries.
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Notes:
Position paper
(1) EuropaBio position paper on naming and labelling can be found here
EuropaBio will attend the WHO stakeholder meeting together with 5 other trade associations (EFPIA, EBE, BIO, PhRMA, IFPMA) representing one voice to the WHO.
About EuropaBio
EuropaBio, the European Association for Bioindustries, has 70 direct members operating Worldwide, 12 associate members and 5 bioregions as well as 24 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of products.
Contact:
Adeline Farrelly
For further information please visit:
EuropaBio
And WHO
Publication Date: 2006-11-13 01:00
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