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KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five regions of Italy – accounting for approximately 20% of the Italian adalimumab market.  Yuflyma® recorded ₩54B (USD$40.7M) of sales in the first half of...

On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars business at its Extraordinary General Meeting.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously e...

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®), to treat metastatic and early breast cancer and metastatic gastric cancer.

On the same day, Novartis...

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...