The Global. The implications that the arrival of new monoclonal antibodies may have for the pharmaceutical market in Spain has focused the interest of the sector after the recent authorizations of biosimilars, whose price fit represents a challenge for the health authorities. Especially when it comes to reconciling the right of patients to new therapies with budget balance. The recent approval of three monoclonal antibodies by the European Medicines Agency (EMA), in addition to the eight that have already been available on the market since 2008, 'are a challenge for the National Health System (SNS). 'assured Sol Ruiz, head of the Biotechnology and Advanced Therapies Division of the Spanish Agency for Medicines and Health Products (Aemps).