Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.

Concerns over the impact of the proposed US BIOSECURE Act on the CRO and CDMO segments linger despite proponent Mike Gallagher’s plan to leave Congress soon. Which global manufacturers could gain, what determines a shift away from Chinese companies and how imminent is this? Scrip brings insights from industry feedback and other sources.

With US biosimilar competition to Humira slow to start in 2023, Organon’s US biosimilars head Jon Martin talks about how the firm is pushing forward to ramp up progress on adalimumab this year, as well as longer-term opportunities.

Trade group’s break from WuXi Apptec allows BIO to reset its lobbying approach under its new CEO but doesn’t negate the business and supply chain disruptions that biopharma would feel from the proposed legislation.