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According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract extends u...

Fresenius Kabi has launched its subcutaneous formulation of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  This new formulation provides patients with primary immunodeficiency diseases a convenient alternative to intravenous...

Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.  The resubmission aims to address “approvability deficiencies” identified i...

On 12 July 2023, Samsung Bioepis UK Limited commenced proceedings against Janssen Biotech Inc in the High Court of Justice of England and Wales seeking to invalidate the UK counterpart patent of European Patent No. EP 3 883 606.  Janssen’s patent relates to the use of ustek...

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).    ADL018 was developed by Kashiv and is curren...

On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the press release,...

On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and ...

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s...

Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppr...