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Apr 5, 2024
On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer (NCT06348199). Biocad initiated phase 1 clinical trials...
Apr 5, 2024
On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is equivalent in efficacy, safety, tolerability and immunogenicity to Amgen’s Prolia®. HLX14 will be indicated for the treatment of osteoporosis in...
Apr 4, 2024
On 4 April 2024, each of Teva Pharmaceuticals and Fresenius Kabi-owned mAbxience announced a strategic licensing agreement relating to an unnamed biosimilar which is already in development for the treatment of multiple oncology conditions. The deal covers multiple...
Apr 3, 2024
The Korea Biomedical Review reported that, on 3 April 2024, the Korean Ministry of Food and Drug Safety approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for the treatment of nAMD and DME. High Dose Eylea® has previously been approved in...
Apr 3, 2024
On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda. On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab). Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form...
Apr 2, 2024
On 2 April 2024, Hangzhou Jiuyan Gene Engineering announced the acceptance of its Chinese application for JiyoutaiTM, biosimilar to Novo Nordisk’s Ozempic® (semaglutide), for type 2 diabetes. This application is reportedly the first in PRC for a semaglutide...
Apr 2, 2024
On 2 April 2024, Korea Biomedical Review reported Samsung Bioepis’ Korean launch of Epysqli®, biosimilar to AstraZeneca’s Soliris® (eculizumab), with a 30% price reduction. Soliris®, developed by Alexion Pharmaceuticals and marketed by AstraZeneca, is used for the...
Mar 31, 2024
The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under evaluation adding 11 new medicines which were accepted for review between February and March 2024. Amongst others, the register shows: In February: MSD’s...
Mar 28, 2024
On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg...
Mar 28, 2024
Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated...
Mar 28, 2024
Merck (MSD) announced that the European Commission approved Keytruda® (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer...
Mar 27, 2024
On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar...
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