Immuno-oncology therapies have revolutionized the treatment of many cancers over the last decade. This period has also witnessed a dramatic growth in China’s domestic pharmaceutical industry, and significant changes in the interaction between this industry and international pharma. This coalescence has led to excitement about the role that Chinese IO could play on the global stage, tempered by regulatory set-backs and revised marketing timelines. 

Coherus BioSciences saw its Q3 revenues tumble by 45% as it arrived at the firm’s projected nadir. A swathe of launches and a cost-cutting program are targeted to bring the firm back to profitability in 2024.

US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.

As part of BsUFA III, the FDA has announced that it will be commencing its regulatory science research program, which will focus on advancing the development of interchangeable products and biosimilars.