Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®)

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08
Oct
2016
Date October 8, 2016
Categories News

Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®)

Biomedcode’s human TNF transgenic arthritis model, (Tg197), contributes to the non-clinical assessment of etanercept biosimilar GP2015 with originator etanercept (Enbrel).

Published in Expert Opinion on Biological Therapy 2016 Vol. 16 , Iss. 10, 1185-1195.

Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel(®)

Hans-Peter Hofmann, Ulrich Kronthaler, Cornelius Fritsch, Roger Grau, Stefan O. Müller, Robert Mayer, Andreas Seidl, and Antonio Da Silva.

In the evaluation process of the proposed biosimilar to Enbrel, GP2015, non-clinical data using the Tg197 model of arthritis confirmed its comparability to the originator with regards to its pharmacokinetic properties, pharmacodynamic activity, efficacy and safety/toxicity.

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