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On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®.

In July 2023, Searle entered into a licence agreement with China’s Mabwell...

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma.  ...

On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September.  Among the changes was the PBS-listing of Amgen’s supplemental denosumab brands, Corora® (60mg/ml PFS) and Ganvado® (70mg/ml vial), referencing Proli...

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation, referencing UCB’s Cimzia®.

In July...

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam:

Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab); and
Herzuma®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Alongside this launch, Celltr...

On 28 August 2025, the UK’s NICE published guidance recommending J&J/Janssen’s Tremfya® (guselkumab) for use within England’s NHS for previously treated moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (UC).

Tremf...

On 28 August 2025, Outlook Therapeutics announced that the US FDA issued a complete response letter (CRL) declining its BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for treating wet age-related macular degeneration (wet AMD).

Ou...

On 28 August 2025, Bayer announced that it has received approval from Korea’s Ministry of Food and Drug Safety for its OcuClick pre-filled syringe (PFS) presentation of Eylea® 8mg (aflibercept).  The PFS presentation is indicated for nAMD and diabetic macular oedema (DME), ...

On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The approval follows the European Medicine Agency’s CHMP positive opinion for the bios...