First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Aspen expects to report significant growth in its continuing operations for the first half of its financial year, following deals with Sandoz and Viatris that have seen the South African firm divest major businesses in Japan and Europe.

Medicines for Europe has called for fresh efforts to bolster the value added medicines sector and “level the playing field” with the US and its 505(b)(2) pathway, launching a new report setting out the three key areas in which greater EU action is needed.