Biotech Industry Welcomes WHO Initiative on
Naming of Biologicals including Biosimilar Medicines
Brussels, 10 November 2006: 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.
For further information, contact
Adeline Farrelly, Tel: +32 2 739 1174 (Direct) Mobile: +32 475 93 17 24
e-mail: a.farrelly@europabio.org
Nathalie Moll, Tel: +32-2-739 11 85 (Direct) Mobile: +32-473 88 45 78
e-mail: n.moll@europabio.org
Notes to Editors
Position paper
(1) EuropaBio position paper on naming and labelling
http://www.europabio.org/positions/EBioPosPaper_Naming_LabellingBiosimilars%20.pdf
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.
http://www.europabio.org
