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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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NEWS

SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America

Shots: SteinCares has entered into a strategic licensing agreement with Shilpa Medicare to commercialize a biosimilar across Latin America (LATAM) As per the deal, SteinCares secures exclusive rights to register, commercialize, & distribute the biosimilar across the region, while SBPL will finalize development & undertake commercial manufacturing at its Dharwad, India facility Partnership combines SBPL’s…
February 25, 2026

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NEWS

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 America As per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin America Dupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…
June 26, 2025

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Lupin & Steincares
NEWS

Lupin Collaborates with SteinCares to Commercialize Ranibizumab Biosimilar in Latin America

Shots: Lupin & SteinCares have entered into a license & supply agreement to commercialize Lupin’s ranibizumab biosimilar in Latin America excl. Mexico & Argentina As per the deal, SteinCares will be responsible for the biosimilar’s regulatory filings, registration, & commercialization in LATAM licensed states, while Lupin will oversee its manufacturing Ranibizumab is a recombinant humanized…
May 26, 2025

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NEWS

Cstone Join Forces with SteinCares to Commercialize Sugemalimab in 10 Latin American Countries

Shots: CStone & SteinCares have partnered to commercialize sugemalimab, where SteinCares will gain its commercialization rights in 10 LATAM countries (incl. Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, & Ecuador), & CStone will handle its supply As per the terms, SteinCares will handle regulatory filings & marketing of sugemalimab in exchange for upfront, regulatory & commercial milestones as well as…
January 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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