India-based life-sciences company Zydus Lifesciences Limited announced on Tuesday that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates, has entered into a strategic partnership with Formycon AG (FSE: FYB), a biosimilar developer based in Germany.
The agreement covers the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda (pembrolizumab), in the USA and Canada market.
Formycon will develop, register, produce and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates, will be responsible for the commercialisation of FYB206 in the defined territories.
The BLA application is expected to be submitted to the US FDA soon and is aimed at making immunotherapy affordable and accessible to patients in need.
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