Skip to content Skip to footer

Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region

Shots:Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnershipsThe agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncologyAs…

Read more

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 disordersApproval 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…

Read more

Bio-Thera & Hikma

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 productApproval 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…

Read more