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On 1 August 2024, GSK announced that the FDA has approved Jemperli® (dostarlimab) in combination with carboplatin and paclitaxel followed by Jemperli® as a single agent for treating primary advanced or recurrent endometrial cancer.  This expands the previous indication for ...

On 1 August 2024, Navlin Daily reported that Brazil’s National Commission for the Incorporation of Technologies into the Unified Health System (CONITEC) recommended against incorporating rituximab monotherapy in Brazil’s national health system for treating asymptomatic foll...

On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

The Health Canada approval foll...

On 31 July 2024, Zydus Lifesciences announced it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market Mamitra™, biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer.

The f...

The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024.

Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to A...

As previously reported, on 9 April 2024, Novartis and Genentech commenced proceedings in the Dusseldorf Local Division of the UPC (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion in relation to EP 2805248 regarding pharmaceuti...

On 31 July 2024, Teva announced that its Q2 2024 revenues increased by 7% to US$4.2 billion.  While much of this is attributed to growth in Teva’s generics business, Teva notes key biosimilar developments, including the May 2024 launch of Teva/Alvotech’s Simlandi® (adalimum...

On 30 July 2024, Biogen and Eisai announced results from their open label extension study of Leqembi® (lecanemab) in early Alzheimer’s Disease.  The data reportedly shows that three years of continuous treatment with lecanemab reduced clinical decline, demonstrating a conti...

On 30 July 2024, Mr Justice Meade of the High Court of Justice of England and Wales delivered his decision in Samsung Bioepis UK Limited’s case against Janssen Biotech Inc seeking to invalidate the UK counterpart patent of European Patent No. EP 3883606 on the grounds of no...

On 30 July 2024, Bio-Thera Solutions announced that the European Medicines Agency (EMA) has approved Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab), for treating various cancers.

In September 2021, Bio-Thera and Sandoz entered an agreement under ...