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On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CH...

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at...

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently ...

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows ...

Pfizer and BioNTech announced that the FDA approved their sBLA for their 2023-2024 COVID-19 vaccine for patients over 12 years of age, and granted emergency use authorisation for patients from 6 months to 11 years old.  The vaccine is an omicron XBB.1.5-adapted monovalent v...

Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new clinical-stage assets, including:

Toripalimab: an anti-PD-1 monoclonal antibody under BLA...

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every ...

Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023.  The target date for the integration of Viatris was end Q3 2023.

On 5 July 2023, Biocon Biologics announced it had completed a ...