Swiss company BioPartners has said that its Valtropin recombinant human growth hormone product has been recommended for approval in the European Union.
Valtropin is the second ‘biosimilar’ rhGH product to receive a positive opinion from the European Medicine Agency’s Committee on Medicinal Products for Human Use (CHMP) after Omnitrope, developed by Novartis subsidiary Sandoz, got a green light last month.
Biologic drugs with sales of $20 billion in 2004 are at immediate risk of generic erosion, once regulators work out a suitable way of proving that they are interchangeable with their branded counterparts and clearing them for market. Europe is way ahead of the USA on this issue, with the first biosimilars – known as ‘follow-on biologics’ in the USA – not expected to reach the latter market until at least 2009.
Commenting on the news, Paul Saenger, professor of paediatrics at the Albert Einstein College of Medicine in New York, USA, said: "if it is granted marketing authorisation, Valtropin will provide paediatric endocrinologists with a more cost-effective treatment option for growth disorders compared with the currently-marketed growth hormone preparations."
BioPartners has also submitted a dossier to the EMEA for a biosimilar version of interferon alpha, a treatment for hepatitis.