Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Shots: The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…

ByRidhi Rastogi2 days ago

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Bio-Thera Solutions and Hikma Pharmaceuticals Receive the US FDA’s Approval for Starjemza (Biosimilar, Stelara)

Shots: The US FDA has approved Starjemza (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product Approval was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK…

ByRidhi RastogiMay 27, 2025

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Hikma Pharmaceuticals Acquires Novugen’s US FDA ANDA Approved Trametinib

Shots: Hikma has acquired the Novugen's US FDA ANDA approved trametinibtablets and also entered into a commercial agreement with Novugen Under the agreement, Hikma will be responsible for all the US sales and marketing of trametinib while Novugen will manufacture and supply them to Hikma. Furthermore, when product is launched Hikma will have 180 days…

ByRidhi RastogiApril 18, 2025

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Bio-Thera Solutions and Hikma Pharmaceuticals Receive the US FDA’s Approval for Starjemza (Biosimilar, Stelara)

Hikma Pharmaceuticals Acquires Novugen’s US FDA ANDA Approved Trametinib

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