Regulatory aspects of biosimilars in Europe

In early 2004, the patent protection for several first-generation biopharmaceuticals began to expire, opening the door to the so-called ‘biosimilars’. The knowledge on biosimilars is steadily growing, and keeping up with state-of-the-art technologies and methods for protein characterization is compelling not only for manufacturers but also for the authorities. The challenges now are to review current marketing approval procedures and to develop standardised methods for evaluating the quality, safety and efficacy of these products.