Abstracts by keywords: evidence requirements
Based on the statements on the GSAV, it can be seen that, among other actors, the medical profession in particular has expressed considerable criticism of the planned regulation on the interchangeability of biosimilars. The National Association of Statutory Health Insurance Physicians (KBV) points out that biosimilars cannot “automatically be substituted by the pharmacist without close monitoring by the doctor” [2]. The Federal Council also expressed clear reservations about the change in the law and stated that there is currently a “lack of valid data to assess the effects of substitution on adherence and therapy results”. At the same time, the Federal Council warns of “a significant risk to the success of a therapy and patient safety” that can be associated with an aut-idem substitution of biosimilars [3]. The National Association of Statutory Health Insurance Funds, on the other hand, expressly welcomes the proposed regulation and regrets the delayed entry into force, which the association finds “also incomprehensible in terms of content” [4]. The present report is intended to contribute to the health policy discussion about the requirements for the underlying evidence for the possible interchangeability of biosimilars.