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On 6 November 2025, Amgen filed two separate BPCIA litigation suits in the US District Court for the District of New Jersey, against each of Dr Reddy’s/Alvotech and Amneal/mAbxience, asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of ...

On 6 November 2025, Biocad announced that it is commencing enrolment for a Phase III clinical trial of BCD-281, biosimilar to Roche’s Ocrevus® (ocrelizumab).  The study, to be conducted in Russia, will aim to evaluate the efficacy and safety of BCD-281 in comparison with Oc...

On 4 November 2025, Sandoz and Evotec SE announced they have signed an agreement for Sandoz’s acquisition of 100% of Just-Evotec Biologics EU SAS (including its Toulouse manufacturing site), together with an indefinite technology licence to Evotec’s continuous manufacturing...

On 4 November 2025, Xbrane Biopharma announced that the first patient has been enrolled in the clinical trial of Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab).  The trial is sponsored by Intas, which entered into a global licence agreement with Xbrane for Xdivane™ in Nov...

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’s Kimberley Evans 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 K...