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On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis (UC), who have had an in...

On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s AVT06 (Mynzepli®), biosimilar to Regeneron/Bayer’s...

On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).  Under the agreement, Bio-Thera will have responsibility for devel...

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 ...