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On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab).  Yesintek® joins five other previously FDA-approved Stelara® biosimilars: Formycon and Fresenius Kabi’s Otulfi® (Septem...

On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab) for the treatment of children 6 years of age and older with moderate-to-severe plaque psoriasis (PsO) a...

On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®.  The petition closely followed a petition filed by Samsung Bioepis in relation to the same patent ...

India’s Medical Dialogues reports that Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug pertuzumab, biosimilar to Roche’s Perjeta®, fo...

On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be added to China’s state-run health insurance scheme.  The addition of the drug, projected to be incorporated from early 2025, will aid in reducing the costs...

On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that,...

On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD).  The product was approved by Korea’s Minist...

On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to Janssen’s Darzalex® (daratumumab), following submission of its global phase 3 clinical trial plan (IND) to the European Medicines Agency (EMA).  

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On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. ...