Samsung Bioepis, the drug development arm of Samsung Group, has launched its Herceptin biosimilar in the UK through its marketing partner MSD, known as Merck & Co (NYSE: MRK) in the US and Canada, the Korea Herald reported on Friday.
MSD began sales of Ontruzant, the first biosimilar copy of Roche's (VTX: ROG) Herceptin, in the UK on Thursday. This means Samsung Bioepis is the first company to bring a cheaper copy of Roche's blockbuster anticancer drug to Europe.
Commercialisation of the drug follows the European Commission's marketing authorisation approval, granted to Samsung Bioepis in November 2017 for the biosimilar for the treatment of early breast cancer, metastatic breast cancer and metastatic cancer.
Ontruzant can now be sold in all 28 European Union member states, as well as the European Economic Area member states of Norway, Iceland and Liechtenstein. The UK is the first state to begin sales of the biosimilar.
The drug is the company's fourth biosimilar to be granted approval from the European regulatory body, and the first cancer-targeting biosimilar in its pipeline to do so. Samsung Bioepis has already received approval for three biosimilars in Europe, referencing Remicade, Enbrel and Humira. These anti-TNF therapies target autoimmune disease, such as rheumatoid arthritis and Crohn's disease.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval