The European Medicines Agency (EMEA) adopted its first ever positive opinion for a similar biological medicinal product in January 2006. The product, Omnitrope, contains growth hormone and is intended for the treatment of growth disturbance in children and adults. It is manufactured by the Swiss drugmaker Novartis AG's generics unit Sandoz GmbH and, according to EMEA's studies, demonstrated comparable quality, safety and efficiency as the reference medicinal product Genotropin, which is manufactured by Pfizer.
Omnitrope was given market authorisation, by the Commission, on 20 April 2006.
The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry.