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On 3 November 2025, Outlook Therapeutics announced that it has re-submitted its Biologics Licence Application (BLA) to the US FDA for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The resubmission follows the company’s Type A meeting wit...

On 2 November 2025, Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics Licence Application (BLA) for AVT05, biosimilar to J&J’s Simponi® (golimumab) in pre-filled syringe and autoinjector presentations.  The CRL follows ...

On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No....

On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows:

DENOLIA (450306) and DESKELTIA (450307) – denosumab 60mg/1mL solution for injection pre...

When is a trade mark application filed in bad faith?

Pearce IP discusses the recent trade mark decision of Rallen Australia Pty Limited v Tamboran Resources Limited [2025] ATMO 212 with ABC‘s Sam Parry in NT Country Hour with Matt Brann.

As explained, “choosin...

On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab).  The study is being conducted in China and is aimed at comparing the efficacy, safety, and immun...

On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively.  This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in New Zealand, foll...

On 30 October 2025, Celltrion announced that, according to IQVIA, its Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), has achieved 50% market share in Japan, surpassing competing innovator and biosimilars to become that top bevacizumab product.  Celltrion...

On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8, biosimilar to Amgen’s Prolia®/Xgeva® (denosumab).  The trial, which was commenced in late 2024, is assessing the efficacy, safety and immunogenici...

The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia® and Xgeva®, respectively, for all approved indications, effective as of 29 October 2025.

Fresenius Ka...