Valtropin^® Recombinant Human Growth Hormone

Status: Approved by EMA.

Human growth hormone (hGH) is secreted by a specialized structure in the brain, the pituitary; it not only induces growth, but also regulates important metabolic effects.

Valtropin^® is Biopartners’ biosimilar rhGH for the treatment of growth hormone deficiency and Turner’s Syndrome. Valtropin^® is administered as a daily injection and its target reference product (for measurement of biosimilarity) is Eli Lilly’s Humatrope^®. Valtropin^® will provide equivalent safety and efficacy, more cost-effectively for a rhGH market in Europe in 2007 that is estimated to be worth 565 million USD*.  

Based on a well designed development program and resulting strong data, Valtropin^® was granted approval by the EMA in April 2006.

* Datamonitor 2005