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Nov 6, 2025
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 denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.
Nov 6, 2025
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).
Nov 4, 2025
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 platform technology (J.POD).
Nov 4, 2025
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).
Nov 3, 2025
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.
Nov 2, 2025
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.
Nov 1, 2025
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. 11,084,865) was valid.
Oct 31, 2025
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…
Oct 30, 2025
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).
Oct 30, 2025
On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively.
Oct 30, 2025
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.
Oct 29, 2025
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).
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