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Traduction de «which is based on similar scientific » (Néerlandais → Français) :

Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific principles already in place in the European Union.

Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.


This advisory report is largely based on expert reports and advisory reports made by the authorities competent for public health, which are themselves based on scientific articles from the international literature and reports of experimental studies.

Le présent avis est basé en grande partie sur des rapports d’expertise et des avis d’autorités de Santé publique, eux-mêmes basés sur la consultation d’articles scientifiques tirés de la littérature internationale et de rapports d’études expérimentales.




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Date index: 2023-05-31
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