BIOSIMILARS UPDATES

19 July 2024 | EU | Gedeon Richter’s EU Denosumab Biosimilars AcceptedOn 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for...

12 July 2024 | HK | IS | Approval Alert: Eisai’s Leqembi® (Lecanemab) Approved in Hong Kong and Israel for Alzheimer's Disease On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong...

7 July 2024 | IN | Approval Alert: Zydus Life Sciences’ Biosimilar Nivolumab Approved in IndiaOn 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee...

28 June 2024 | Shanghai Henlius Biotech Completes Phase 1 Trials for Daratumumab Biosimilar Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab).  The studies...

14 June 2024 | AU | Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Australia On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection...

31 May 2024 | EU | US | Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has...

24 MAY 2024 | EU | Shanghai Henlius’ & Organon’s Biosimilar Denosumab Applications Validated by EMA On 24 May 2024, Shanghai Henlius and Organon announced that the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications...

17 MAY 2024 | KR | New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Korea for New NSCLC and Cervical Cancer Indications On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and...