Press release from EuropaBio
Bioindustry welcomes new French legislation covering biosimilar medicines
Brussels, 21 February 2007
The European biotechnology industry represented by EuropaBio – the EU association for bioindustries - welcomes the passing into law of legislation covering biosimilar medicines (1) in France. On 6 February 2007, the French Parliament has adopted legislation that prevents biosimilar medicinal products from being classed as generics and bans the automatic substitution of one biological medicine for another.
The law confirms the EU legal definition of a “biosimilar” medicine and recognises the uniqueness of this new generation of products. It states that they cannot be classified as “generics” in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.
Commenting on the adoption of the new legislation, EuropaBio’s Chair of the Healthcare Council, Andrea Rappagliosi said “We strongly appreciate the efforts made by the French government in pursuing a patient-centred vision by promoting innovation in healthcare”.
The ban on the automatic substitution of one biological medicine over another reinforces the central role of the physician-patient relationship that is mandatory in order to deliver the most effective treatment to an individual patient when using biotech-derived therapies.
“Overall”, - continued Mr. Rappagliosi – “this legislation achieves the primary objectives in healthcare: to deliver safe and effective care”.
(1) Biosimilar medicines are copies of original or “innovator” biotechnology medicines, which are similar but not identical to the original product, hence they are “biosimilar” and not “biogenerics”
For further information, contact:
Adeline Farrelly, EuropaBio, Tel: +32 2 735 0313 Mobile: +32 475 931724
Email: [email protected]
About EuropaBio
EuropaBio, the European Association for Bioindustries, has 70 direct members operating Worldwide, 12 associate members and 5 bioregions as well as 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products. www.europabio.org <http://www.europabio.org/>
Bioindustry welcomes new French legislation covering biosimilar medicines
Brussels, 21 February 2007
The European biotechnology industry represented by EuropaBio – the EU association for bioindustries - welcomes the passing into law of legislation covering biosimilar medicines (1) in France. On 6 February 2007, the French Parliament has adopted legislation that prevents biosimilar medicinal products from being classed as generics and bans the automatic substitution of one biological medicine for another.
The law confirms the EU legal definition of a “biosimilar” medicine and recognises the uniqueness of this new generation of products. It states that they cannot be classified as “generics” in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.
Commenting on the adoption of the new legislation, EuropaBio’s Chair of the Healthcare Council, Andrea Rappagliosi said “We strongly appreciate the efforts made by the French government in pursuing a patient-centred vision by promoting innovation in healthcare”.
The ban on the automatic substitution of one biological medicine over another reinforces the central role of the physician-patient relationship that is mandatory in order to deliver the most effective treatment to an individual patient when using biotech-derived therapies.
“Overall”, - continued Mr. Rappagliosi – “this legislation achieves the primary objectives in healthcare: to deliver safe and effective care”.
(1) Biosimilar medicines are copies of original or “innovator” biotechnology medicines, which are similar but not identical to the original product, hence they are “biosimilar” and not “biogenerics”
For further information, contact:
Adeline Farrelly, EuropaBio, Tel: +32 2 735 0313 Mobile: +32 475 931724
Email: [email protected]
About EuropaBio
EuropaBio, the European Association for Bioindustries, has 70 direct members operating Worldwide, 12 associate members and 5 bioregions as well as 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products. www.europabio.org <http://www.europabio.org/>
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