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Sep 2, 2025
On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to…
Sep 2, 2025
On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.
Sep 1, 2025
On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake in the company.
Sep 1, 2025
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®.
Sep 1, 2025
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 &
Sep 1, 2025
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
Sep 1, 2025
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
Aug 28, 2025
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).
Aug 28, 2025
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
Aug 28, 2025
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™
Aug 28, 2025
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
Aug 26, 2025
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
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