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.

The approval establishes Trodelvy-based treatment across PD-L1 status in first-line metastatic TNBC in Europe, following the earlier authorisation of Trodelvy monotherapy for patients not eligible for PD-1/PD-L1 inhibitors.

If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The approvals expand the use of Keytruda and Keytruda Qlex alongside Padcev into the perioperative treatment setting for adults with muscle-invasive bladder cancer.

The US Food and Drug Administration (FDA) has approved a combination regimen of Merck & Co.’s Keytruda (pembrolizumab) and Welireg (belzutifan).

Keytruda now approved across EU for PD-L1-positive platinum-resistant ovarian, fallopian tube, and primary peritoneal carcinoma.