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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...

On 16 August 2024, Bio-Thera announced that it has entered into a licensing and supply agreement with Pharmapark for BAT2306, biosimilar to Cosentyx® (secukinumab).  Under the agreement, Pharmapark will have exclusive rights to distribute and market BAT2306 in Russia and ot...

On 16 August 2024, AstraZeneca announced that the FDA has approved its Imfinzi® (durvalumab), in combination with chemotherapy, for resectable early stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinas...

On 15 August 2024, Alvotech and Advanz Pharma announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept).  The companies expect EMA marketing authorisat...

On 15 August 2024, Alvotech announced its financial results for the first half of 2024, reporting total revenues of US$236 million, a more than 10-fold increase compared to 1H 2023, and product revenues of US$66 million, up 190% from 1H 2023.  Its EBITDA was positive for th...

Incyte has announced positive results from a pivotal study of tafasitamab (Monjuvi®) in relapsed or refractory follicular lymphoma.

Based on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment ...