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 Publications

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

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. Expert Opinion on Biological Therapy Vol. 16 , Iss. 10, 2016

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

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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