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On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The new presentation is approved for the treatment of paediatric patients aged ...

On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi.  The Fresenius patent,  E...

On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.

With the new...

On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 as determined by an FDA-approved test.  Keytruda® is approved as ...

On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

Xbrane’s biosimilars include Ximluci®, biosimilar to G...

On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD.

Earlier this month, Outlook Therapeutics announced that it had launched Lytenav...

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infrin...

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab).

Under the terms of the agreement, Sam...