On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement...
Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar
On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17),...
Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland
On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab) biosimilar FYB201 in...
Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)
On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for...
Samsung Bioepis Releases Fifth Biosimilar Market Report: Adalimumab Biosimilar Uptake at 4% Following First Year of Biosimilar Competition
On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report. The quarterly report details average...
Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar
On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Prolia®)...
Samsung Bioepis Commences Phase 3 Trials for Keytruda® Biosimilar
On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s...
Shanghai Henlius’ Ph 3 success for Prolia® biosimilar HLX14 (denosumab)
On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is...
Teva and mAbxience Global Licensing Deal for Oncology Biosimilar Candidate
On 4 April 2024, each of Teva Pharmaceuticals and Fresenius Kabi-owned mAbxience announced a strategic licensing...
Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Korea
The Korea Biomedical Review reported that, on 3 April 2024, the Korean Ministry of Food and Drug Safety approved...
Sandoz’s High Concentration Adalimumab Biosimilar on AU July PBAC Agenda
On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda. On the list of drugs seeking to be PBS...
Hangzhou Jiuyan Gene Engineering Files Semaglutide Biosimilar Application in China
On 2 April 2024, Hangzhou Jiuyan Gene Engineering announced the acceptance of its Chinese application for JiyoutaiTM,...
Samsung Bioepis Launches Soliris® (eculizumab) Biosimilar in Korea with 30% Price Drop
On 2 April 2024, Korea Biomedical Review reported Samsung Bioepis’ Korean launch of Epysqli®, biosimilar to...
Transparency Measures Glitch Resolved: AU’s TGA publishes “catch up” list for medicines accepted between February and March 2024
The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under...
Celltrion Launches US Pediatric High Concentration Adalimumab Biosimilar
On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to...
China National Medical Products Administration (NMPA) Accepts sBLA for enfortumab vedotin and Keytruda® (pembrolizumab) Combination Treatment of Urothelial Cancer
Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics...