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Aug 23, 2024
On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals. The following biosimilars were recommended...
Aug 22, 2024
On 22 August 2024, Pfizer Canada announced that Padcev® (enfortumab vedotin) in combination with MSD’s Keytruda® (pembrolizumab) has been approved by Health Canada for treatment of unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior...
Aug 22, 2024
On 22 August 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, the Henlius-developed biosimilar to Roche’s Herceptin® (trastuzumab) to treat early/metastatic...
Aug 22, 2024
On 22 August 2024, AbbVie announced that the UK’s National Institute for Health and Care Excellence (NICE) issued final Technology Appraisal Guidance recommending Skyrizi® (risankizumab) as a treatment option for adults with moderately to severely active ulcerative...
Aug 22, 2024
On 22 August 2024, Eisai and Biogen announced that Leqembi® (lecanemab) has received marketing authorisation from the UK’s MHRA for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease. The UK is the first country in Europe to...
Aug 21, 2024
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable...
Aug 20, 2024
On 20 August 2024, the FTC and US Biosimilars Council lent their support to the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines. In draft guidance published by the FDA...
Aug 19, 2024
On 19 August 2024, AbbVie announced that the European Commission (EC) has granted conditional marketing authorisation for its Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more...
Aug 19, 2024
On 19 August, Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated a Type II Variation Application for the use of Enhertu® (trastuzumab deruxtecan) as a form of monotherapy treatment for individuals with unresectable or metastatic HER2 low...
Aug 19, 2024
A number of biopharmaceuticals and biosimilars are potentially in line for September listings on Australia’s Pharmaceutical Benefits Scheme (PBS). UCB’s Bimzelx® (bimekizumab) has progressed to the last stage before PBS listing for psoriatic arthritis and ankylosing...
Aug 19, 2024
On 19 August 2024, Taiwanese-based GlycoNex announced that SPD8, biosimilar to Amgen’s Prolia® (denosumab), is expected to enter a Phase 3 clinical trial in Q4 2024. The trial will assess the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis....
Aug 19, 2024
Celltrion announced on 19 August 2024 that the FDA has approved a phase 3 clinical trial of Zymfentra™ (CT-P13 SC, infliximab SC) for rheumatoid arthritis (RA). In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for...
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