New EU GDP Guidelines – Part II
The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013. But only a few months later the GDP had to be renewed. The new version 2013/C 343/01 ...Apotex Canada received its first Biosimilar registration in Europe of Amgen’s blockbuster cancer treatment filgrastim!
Apotex's version of filgrastim received regulatory approval from the European Commission. Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost ...Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea
On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original ...
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