Regulatory challenges for nanosimilars
- At: 2019 FIP Congress in AbuDhabi (United Arab Emirates)
- Type: Presentation
- By: SHAH, Vinod (NBCD Working Group, USA)
Nanomedicines are typically synthetic and belong to Non-Biological Complex Drug Products (NBCDs). The high complexity relates to their composition of closely related but not homomolecular, often nanoparticular structures. The regulatory approval of NBCDs is challenging because of the difficulties in complete characterization of the drug product.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.