Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 7 February 2025 are set out...
Home / Search Results
Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.
By Naomi Pearce, Chantal Savage, Nathan Kan | Feb 10, 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 7 February 2025 are set out...
By Bioblast Editor | Feb 10, 2025
On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting another.
AstraZeneca’s Imfinzi® (durvalumab) will be reimbursed for use i...
By Bioblast Editor | Feb 10, 2025
On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.2 mg/ml solution for injection) for nAMD ...
By Bioblast Editor | Feb 09, 2025
Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300m...
By Bioblast Editor | Feb 08, 2025
On 8 February 2025, at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting, Regeneron presented positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept, 8 mg injection, known as Eylea™ 8mg in the EU and Japan) for ...
By Bioblast Editor | Feb 07, 2025
On 7 February 2025, Bio-Thera announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).
BAT2506 is being developed and manufactured by Bio-Thera and will be...
By Bioblast Editor | Feb 07, 2025
On 7 February 2025, the Australian Therapeutic Goods Administration (TGA) approved UCB’s Rystiggo® (rozanolixizumab) in 140mg/mL solution for injection, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-...
By Naomi Pearce, Helen Macpherson, Nathan Kan | Feb 06, 2025
Commonwealth of Australia v Sanofi [2024] HCA 47
Date of decision:
11 December 2024
Body:
High Court of Australia
Adjudicator:
By Bioblast Editor | Feb 06, 2025
On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius Kabi and Accord Biopharma are infringing US patents covering Amgen’s Prolia® and Xgeva® (d...
By Naomi Pearce, Helen Macpherson, Nathan Kan | Feb 06, 2025
Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd [2024] FCA 1488
Date of decision:
17 December 2024
Body:
Federal Court of Austra...
SUBSCRIBE TO PEARCE IP