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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
Aug 26, 2025
On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to
Aug 26, 2025
On 26 August 2025, Abbott announced that it has secured regulatory approval for the first denosumab biosimilar, referencing Amgen’s Prolia®/Xgeva®, in Thailand.
Aug 25, 2025
On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab. Under the agreement, Bio-Thera will maintain
Aug 25, 2025
On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy
Aug 22, 2025
At its July 2025 meeting, Australia’s Pharmaceutical Benefits and Advisory Committee (PBAC) rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in
Aug 22, 2025
On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on
Aug 22, 2025
On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab
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