Second biosimilar gains EU marketing authorisation

Biopartners, a privately-owned biopharmaceuticals company headquartered in Baar, Switzerland, has received EU marketing authorisation from the European Commission for Valtropin (somatropin), a biosimilar recombinant human growth hormone used for the treatment of human growth deficiency in children and patients with Turner's Syndrome.

Valtropin is only the second biosimilar to receive EU marketing authorisation from the European Commission. Human growth hormone is produced in the pituitary gland and exerts its actions both through direct effects on tissues (for example, through bone and cartilage) and through a family of molecules known as somatomedins, such as insulin-like growth factor 1 (IGF-1). Paediatric human growth hormone deficiency can occur at any time during infancy or childhood and is found in one in every 4,000 children globally.

"We are delighted to have gained EU marketing authorisation for Valtropin," said Jean-Noel Treilles, ceo of Biopartners. "As the first product in our pipeline to gain authorisation, it marks a major milestone for Biopartners. We aim to make Valtropin available to healthcare professionals and patients through our distributors before the end of the year."

"Valtropin will provide paediatric endocrinologists with a more cost-effective treatment option for growth disorders compared to the currently marketed growth hormone preparations, and this in turn will allow us to treat more patients," said Paul Saenger, professor of paediatrics at the Albert Einstein College of Medicine in New York, US and principal investigator on BioPartners' Phase III study of Valtropin in human growth deficiency in children.

Biopartners in-licensed Valtropin from Korean company LG Life Sciences and has commercialisation rights for the product in Europe, Japan and other parts of Asia. The two companies are currently developing a sustained release version of the drug that is in Phase III clinical trials.