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Nov 7, 2025
On 7 November 2025, Medical Dialogues reported that Zydus Lifesciences has received tentative approval from the FDA for olaparib tablets, 100 mg and 150 mg, referencing AstraZeneca/MSD’s Lynparza®.
Nov 7, 2025
On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (BA6101; biosimilar to Amgen’s Prolia®) and 120mg (BA1102; biosimilar to Amgen’s Xgeva®).
Nov 6, 2025
On 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). This is the first biosimilar Hikma has launched in the US.
Nov 6, 2025
On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European commercialisation of Pyzchiva® (SB17), biosimilar to Stelara® (ustekinumab).
Nov 6, 2025
On 6 November 2025, Alvotech and Advanz Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Gobivaz®(AVT05), biosimilar to J&J’s Simponi® (golimumab).
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.
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