Biosimilars

Valtropin® recombinant human growth hormone.

Valtropin

Status: Approved by EMA.

Human growth hormone (hGH) is secreted by a specialised 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 €550 million.

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