HPE HPE Fresenius Kabi handbook - Page 16

EU regulatory policies, mainly established by guidelines issued by the EMA and revised periodically, can now draw upon more than a decade of experience manufacturer could be held liable in failure to warn or design defect claims is limited. 9 From a medical liability perspective, if a patient switched to a biosimilar experiences adverse events or loss of efficacy, the medical liability chain will be different from that in the case of generics. Moreover, the case of treatment-naïve patients will be different from that of non-naïve patients. In the case of naïve patients, physicians choose from a range of medicinal products with the same unknown/the same risk (it is not possible to know patients’ responses to each therapeutic option until they have taken the drug). In contrast, in the case of non-naïve patients, when physicians switch to a biosimilar, they are switching from an option where the individual response is known to an option where it is unknown. 9 16 | 2019 | hospitalpharmacyeurope.com The EU legislative framework In the EU, biotechnological medicinal products fall under the provisions of Regulation EC No. 726/2004, while the legal basis for biosimilars lies in the Directive 2001/83/EC (as amended). The authorisation process for biosimilars of polypeptide- based products is the same as that of protein-based products. The regulatory policy for biosimilars is outlined mainly in general and product class-specific guidelines issued by the EMA, addressing quality, non-clinical and clinical issues. 10 Table 1 summarises some of the guidelines. The MA application is supported by a dossier containing the required data in a standard format (known as the common technical document (CTD)). The CTD is composed of five modules: • Module 1: specific administrative data;