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On 10 March 2026, The Pharma Letter reported that Roche subsidiary, Genentech, had begun legal proceedings before the Moscow Arbitration Court alleging patent infringement by Biocad’s biosimilar to Perjeta® (pertuzumab), Pertuvia™.  Pertuvia™ was approved for sale in Russia...

On 10 March 2026, Sandoz announced the creation of a new global biosimilar development, manufacturing and supply unit, which will come into effect on 1 April 2026.

According to Sandoz, separating the biosimilar and generic development and manufacturing units will all...

On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost of medicines for consumers.  In the new draft guidance, FDA “r...

On 5 March 2026, J&J announced the US approval of Tecvayli® (teclistamab-cqyv) in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of relapsed or refractory multiple myeloma (RRMM) as a second line treatment.

This approval ...

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...