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Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

Shots:Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin AmericaAs per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin AmericaDupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…
June 26, 2025

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Bio-Thera New
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Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots:The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference productOpinion 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 &…
June 23, 2025

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Bio-Thera & Hikma
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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 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…
May 27, 2025

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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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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 potencyBiosimilars 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 patientsDuring 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 potencyBiosimilars 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 patientsDuring the month of June, Samsung Bioepis presented results of SB12…
July 5, 2023

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