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See Latest ArticlesRegulatory aspects of biosimilars in Europe
Trends in Biotechnology , 06/29/09
Zuniga L et al. - 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.
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