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NEWS

Orion Pharma Expands Partnership with Shilpa Medicare for Nivolumab Biosimilar in the EU 

Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across the EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development &…
July 6, 2026

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Henlius & Organon
NEWS

Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada

Shots: Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty Denosumab is a mAb that works…
June 23, 2026

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Samsung Bioepis and Organon
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Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

Shots: Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, a biosimilar version of Stelara (ustekinumab), with launch expected in 2026 As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities. The addition of Pyzchiva expands the…
June 18, 2026

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NEWS

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx) 

Shots:  The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic  The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…
June 18, 2026

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NEWS

CinnaGen Reports the EC Approval of Zandoriah (Biosimilar, Forsteo)

Shots: The EC has granted centralized marketing authorization to Zandoriah, a biosimilar version of Forsteo (teriparatide) for the treatment of osteoporosis in adults, across all 30 EEA states Zandoriah has demonstrated biosimilarity in line with EMA guidelines, with comprehensive comparability studies confirming similar quality, safety, and efficacy to the reference product Teriparatide is a synthetic…
June 16, 2026

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NEWS

SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara) 

Shots:  The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab)  Ustekinumab is a human interleukin-12 and -23 antagonist  Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis  Ref: Gov.br |   Image: SteinCares | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea   PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…
June 15, 2026

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Celltrion
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Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea) 

Shots:  The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)  Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor  Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)  Ref: Gov.br |   Image: Celltrion   | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  …
June 15, 2026

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