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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 hepatocellular car...

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In draft guidance published by the FDA ...

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 lines...

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 or HER2...

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 ...

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.

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 ...

On 16 August 2024, Janssen Biotech, Inc and Janssen-Cilag Pty Ltd commenced patent infringement proceedings against Samsung Bioepis AU Pty Ltd in the Federal Court of Australia. The proceeding is yet to be listed for a first case management hearing.

This is the secon...