Biosimilars

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Shots: Bio-Thera Solutions has commenced the patients dosing under the combined P-...

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Shots: The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating...

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Shots: The US FDA has granted approval to the company’s BLA of Epysqli (ecul...

Alvotech Reports Data from Confirmatory Trial of AVT03 (Biosimilar, Prolia and Xgeva)

Alvotech Reports Data from Confirmatory Trial of AVT03 (Biosimilar, Prolia and Xgeva)

Shots: Alvotech has reported data from the confirmatory P-III (

Kashiv BioSciences Partners with Amneal Pharmaceuticals to Commercialize ADL018 (Biosimilar, Xolair)

Kashiv BioSciences Partners with Amneal Pharmaceuticals to Commercialize ADL018 (Biosimilar, Xolair)

Shots: Kashiv BioSciences has signed an exclusive licensing agreement with Amneal...

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), fo...

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