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On 18 September 2026, Sandoz announced that Health Canada has approved Sandoz® Semaglutide, a generic version of Novo Nordisk’s Ozempic® (semaglutide).  This is in line with Sandoz’s expectations for a 2026 launch of the product.

Sandoz® Semaglutide is approved...

On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for the following two biosimilars.

Alvotech/Advanz’s Adcomfo® (omalizumab)...

On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for new biopharmaceuticals and indication extensions for already approved medicines....

On 18 September 2026, Sandoz and mAbxience announced they have entered a licensing, development, manufacturing and commercialisation agreement in relation to a biosimilar to Roche/Chugai’s Hemlibra® (emicizumab).  The biosimilar is in early stage development and will be the...

September 2026 has been a busy month for ranibizumab with two new registrations on the Australian Register of Therapeutic Goods (ARTG): Novartis’ Vurjor® (1.65mg/0.165mL solution prefilled syringe (18 September)) and Roche’s Susvimo® (100mg/mL solution for injection vial fo...

On 17 September 2026, India-based contract development and manufacturing organisation (CDMO) Shilpa Biologicals announced that it has signed an exclusive licence and commercialisation agreement with Saudi Arabia-based SPIMACO Bio for a “portfolio of PD-1 inhibitor biosimila...

On 16 September 2026, Daiichi Sankyo announced that Japan’s Ministry of Health, Labour and Welfare has approved Enhertu® (trastuzumab deruxtecan) and Datroway® (datopotamab deruxtecan) for two new breast cancer indications.  Enhertu®, in combination with pertuzumab (R...

On 16 September 2026, MSD’s subcutaneous pembrolizumab was approved in Japan under the name Keyject™.  Keyject™ (pembrolizumab and berahyaluronidase alfa) is approved for the same indications as Keytruda® (IV formulation) and is the first subcutaneous immune checkpoint inhi...

On 16 September 2026, Teva filed an application seeking declaratory judgment of non-infringement and invalidity in relation to 14 Janssen patents asserted against Alvotech in BPCIA litigation commenced on 19 June 2026 in the US District Court for the Eastern District of Vir...