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Bio-Thera & Hikma
News

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…
May 27, 2025

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News

Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance

Shots:  Bio-Thera Solutions has expanded its collaboration with SteinCares, granting it exclusive rights to market a third biosimilar in Brazil and the LATAM region  Bio-Thera will handle development, the US FDA & the EMA submissions to support LATAM regulatory filings & commercial supply of each biosimilar from its Chinese manufacturing facilities  SteinCares will utilize its…
December 16, 2024

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News

Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM 

Shots:  Bio-Thera Solutions and SteinCares have entered into a new licensing agreement for marketing two biosimilars as per which SteinCares gains exclusive distribution and marketing rights to Bio-Thera's products across Brazil and the rest of the region  Under the agreement, Bio-Thera will handle the biosimilars’ development & regulatory submissions with the US FDA & the…
March 18, 2024

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Insights+ Key Biosimilars Events of July 2023
INSIGHTS+

Insights+ Key Biosimilars Events of July 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of July, Samsung Bioepis reported P-III equivalence study…
August 4, 2023

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Insights+ Key Biosimilars Events of June 2023
INSIGHTS+

Insights+ Key Biosimilars Events of June 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of June, Samsung Bioepis presented results of SB12…
July 5, 2023

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