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On 5 March 2026, Outlook Therapeutics provided an update on ONS-5010/Lytenava™, ophthalmic biosimilar to Roche/Genentech’s Avastin® (bevacizumab-vikg), following a Type A meeting with the U.S. Food and Drug Administration (FDA).

The Type A meeting was held to clarify...

On 4 March 2026, CSPC Pharmaceutical Group announced that it has received approval from China’s National Medical Products Administration (NMPA) to begin clinical trials of its emicizumab injection (SYS6053), a biosimilar to Roche’s Hemlibra® (emicizumab), for th...

On 3 March 2026, Janssen Biotech Inc and Janssen Sciences Ireland UC filed proceedings against Bio-Thera Solutions and Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to golimumab.  The Court has granted Ja...

On 3 March 2026, Moderna entered into a settlement with Arbutus Biopharma and Genevant Sciences to resolve the global COVID patent litigation, including the lengthy dispute in the US District Court for the District of Delaware.  This settlement comes days before the schedul...

On 1 March 2026, Australia’s Pharmaceutical Benefits Scheme published its summary of changes.  Among the changes is the expansion of the PBS listing for nivolumab and ipilimumab to enable broader access for the treatment of advanced or metastatic cancers.

The Austral...

On 27 February 2026, Genentech filed a complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS infringed four US patents: US8652474 (for pharmaceutical compositions comprising a HER2 antibo...

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its February 2026 meeting, including positive opinions for 6 biosimilars: Shanghai Henlius/Organon’s Poherdy® (HLX11) (pertuzumab), Gedeon Ri...