Turkey has specialized in biotechnologies, not only to satisfy the strong domestic demands (Turkey is the 6th largest market in Europe, one of the fastest growing markets),
but also to meet the needs of other emerging markets. Authorization procedures for biosimilar products are therefore rather simple. In order to obtain the approval, the Applicant must submit an abridged application to the Turkish Competent Authority. As in the European biosimilar applications, the similarity must be demonstrated between the product under registration and the reference product, i.e. an authorized original biologic product. The demonstration of the similarity must cover the product quality, characteristics, biological activities, safety, and efficacy. Also data from foreign clinical studies can be submitted, provided that they are approved by the relevant Competent Authority.
More biosimilars on the Turkish market
