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On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (C...

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab).  According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”.  This includes Enzene’s parent company, A...

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following presentations:

20mg/0.2mL (484565) and 40mg/0.4mL (484554) injection solution ...

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) ...

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults across 38 indications, covering most solid tumour indications for Keytruda® (pembrolizumab).  MSD is...

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway.  The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within t...

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:

Golimumab: AVT05 (GOLIMUMAB BS 50 mg PFS for subcutaneous injection)...

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:

Golimumab: Alvotech/Advanz Pharma’s Gobivaz® ...

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).

The study, which was conducted across 40 sites in five European countries on 446 postmenopausal...

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

The European Medicines Agency’s ...