Industry Updates — Full Archive

US FDA accepts first Keytruda® biosimilar application from Zydus–Formycon

The US Food and Drug Administration has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to pembrolizumab (Keytruda®), jointly developed by Zydus Lifesciences and Formycon AG. The companies say this is the first publicly announced US FDA acceptance of a Keytruda® biosimilar filing.

The BLA was submitted in Q3 2026, and a decision is expected in Q3 2027 under the US biosimilar review timeline. Zydus holds exclusive commercialisation rights for the United States and Canada, and the dossier has also been filed with Health Canada. FYB206 was developed without a comparative Phase III efficacy trial, under a pathway agreed with the US FDA in February 2025.

Pembrolizumab is a PD-1 immune checkpoint inhibitor used across many cancer types. Worldwide sales of Keytruda® reached USD 31.7 billion in 2025.

Zydus Lifesciences press release, 13 Oct 2026

FDA approves Bixlenvo (bictegravir/lenacapavir), smallest single-tablet HIV regimen

Gilead's Bixlenvo combines bictegravir 75mg and lenacapavir 50mg into the smallest once-daily single-tablet regimen for virologically suppressed HIV patients, offering the first single-tablet option for patients unable to take currently available regimens. A meaningful new option for treatment-experienced HIV patients.

Gilead Sciences press release, 27 Aug 2026

FDA approves daraxonrasib (Rasonque) for metastatic pancreatic cancer

Approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy — a RAS GTPase inhibitor addressing a historically hard-to-treat cancer.

US FDA announcement, 26 Aug 2026

FDA approves zanidatamab-hrii (Ziihera) for HER2-positive gastric cancer

Approved in combination with chemotherapy and tislelizumab as first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Expands first-line options in HER2+ GI cancers.

US FDA announcement, 25 Aug 2026