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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®.

In February 2025, AstraZeneca and MSD’s Lynparza® was accepted in Sco...

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; bio...

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.

Starjemza™ was approved by the FDA in May 2025.  It is commercialised ...

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).

While the terms of the ag...

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).  The approval covers both pre-filled syringe and autoinjector dosage ...

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...