Having already launched one of its denosumab biosimilar products in China, Boan Biotech has now commenced an international Phase III study to secure approval in Europe, the US and Japan.

In Vivo asked six biopharma figureheads to share their thoughts on the state of leadership in the life sciences space, exploring the qualities of a great leader, how recent years have shaped this role within the industry and the challenges ahead.

Months after announcing that its GP2411 biosimilar denosumab candidate was accepted for filing by the FDA, Sandoz has been sued for alleged patent infringement by originator Amgen.

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.