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Jun 23, 2025
On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®…
Jun 20, 2025
Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®)…
Jun 20, 2025
On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab)…
Jun 20, 2025
On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab…
Jun 19, 2025
On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab)…
Jun 19, 2025
On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary…
Jun 19, 2025
On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025…
Jun 17, 2025
On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept)…
Jun 16, 2025
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)…
Jun 16, 2025
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…
Jun 12, 2025
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…
Jun 12, 2025
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…
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