What are Wave 3 biologics and why are they attracting little to no biosimilar competition? Wave 3 biologics are the latest wave of complex biologics characterized by rising levels of manufacturing, clinical testing and logistical complexity. This cohort comprises antibody-drug conjugates (ADC), cell and gene therapies (or Advanced Therapy Medicinal Products; ATMPs), oligonucleotides and PD-1 inhibitors. Wave 3 includes products facing LoE (loss of exclusivity) events by 2032. Although not all of these products target rare diseases, a rising share of them do. There are currently no candidates for any of these complex orphan drugs, but there are 16 candidates for non-orphan, Wave 3 biologics. The chart shows the pipeline for these biologics, which includes an early asset (Phase I) referencing trastuzumab emtansine, eight biosimilar candidates for pembolizumab and seven for nivolumab. Yet, not all these candidates are expected to progress to clinical trials or enter the European market following the expiry of patents and other exclusivity rights because of challenges to development and feasibility. IQVIA Institute’s Assessing the Biosimilars Void report further discusses the factors that affect the development and launch of new biosimilars for these complex biologics. Download the report here: https://bit.ly/46DMeZp. #GlobalHealth #Datascience #Biosimilars
