EMA: new molecule authorisations
In 2013 the EMA authorised 38 drugs containing active substances that had never previously been used. Additionally, two new innovative-therapy drugs were recommended for approval in 2013. Derived from gene therapy and cell therapy, they offer new opportunities for the treatment of illnesses and injuries. The number of market approval recommendations for drugs designed for rare diseases has been constantly growing (11 in 2013 against 8 and 4 in the previous two years). 2013 also saw the first two positive opinions on market authorisations for biosimilar monoclonal antibodies. Across the Atlantic, the FDA authorised 27 new products, including 9 for the treatment of rare diseases.