Biosimilars

Biosimilars (also called biogenerics or follow-on biologics) are biological pharmaceuticals that are produced by recombinant DNA technologies and are clinically proven to be similar to a reference first-generation product already authorized in the EU.

The EMEA grants a marketing authorization to a biosimilar when it has been compared to, and matches with, the reference medicine in terms of quality (how it is made), safety (for example the side-effects that can occur when receiving treatment) and efficacy.

In 2006, Biopartners received marketing authorization from the EMEA for Valtropin^®, a biosimilar recombinant human growth hormone for the treatment of human growth hormone deficiency in children and Turner’s syndrome.

Products

• Valtropin^® - Recombinant Human Growth Hormone (Daily Formulation)