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On 11 March 2026, Celltrion announced the European launch of its Remsima® IV liquid formulation, biosimilar to Janssen’s Remicade® (infliximab).  This follows the November 2025 approval of Remsima® IV liquid formulation by the European Commission for the treatment of rheuma...

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On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost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  In the new draft guidance, FDA “r...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