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On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Freseniu...

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report.  The quarterly report details average sales price information for US launched biosimilars and market share and price trends.
The Q2 2024 Report notes that as of April 2024, the FDA has ap...

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Xgeva®) received marketing approval in China.  MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab.  It is approved in China for the treatment of giant cell...

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 f...

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 postmenop...

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 markets,...

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...

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 and reim...