NICE has issued positive final draft guidance for perioperative Padcev and Keytruda in muscle-invasive bladder cancer, potentially expanding NHS treatment access before and after surgery for eligible patients regardless of cisplatin suitability.

The FDA has converted Keytruda's tumour-mutational-burden-high solid tumour indication to traditional approval, extending the authorisation to Keytruda Qlex and updating the biomarker threshold.

The European Commission has authorised Keytruda plus Padcev before and after surgery for adults with resectable muscle-invasive bladder cancer, expanding perioperative treatment options in the EU.

Orion Pharma and Qilu Pharma Europe have entered a European commercialisation agreement for a proposed intravenous pembrolizumab biosimilar.

STADA and SBP Group have launched a strategic biosimilars partnership beginning with a proposed Keytruda biosimilar and providing a framework for up to three additional programmes.

The agreement gives Cipla exclusive US commercialisation rights to Qilu Pharmaceutical's pembrolizumab biosimilar candidate QL2107, referencing Keytruda.