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Fresenius Kabi
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Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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Key Biosimilars Events of December 2024

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 patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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Key Biosimilars Events of December 2024
INSIGHTS+

Key Biosimilars Events of December 2024

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 patients        A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia 

Shots:  Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia  The alliance will utilize Tabuk's local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities  BAT2206, a proposed biosimilar to…
December 24, 2024

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News

Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara) 

Shots:  Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Janssen's Stelara (Ustekinumab), following CHMP’s positive opinion & FDA's approval  Imuldosa, initially developed by Dong-A Socio Holdings & Meiji Seika Pharma, & was transferred to Dong-A ST in 2020 for global development and commercialization. In 2021, it was out-licensed to Intas Pharmaceuticals for…
December 19, 2024

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Celltrion
News

The US FDA Grants Approval to Celltrion’s Steqeyma (Biosimilar, Stelara) 

Shots:  Celltrion has receive the US FDA’s approval for Steqeyma, biosimilar version of J&J’s Stelara (ustekinumab), to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, & ulcerative colitis  The approval was supported by P-III study in mod. to sev. plaque psoriasis with 1EP as change in the PASI for skin symptoms, showing therapeutic equivalence b/w Steqeyma…
December 17, 2024

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Key Biosimilars Events of October 2024
INSIGHTS+

Key Biosimilars Events of October 2024

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 patients        The major highlights were the US FDA’s approval of Dong-A ST’s Imuldosa…
November 5, 2024

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Disease of the Month – Psoriatic arthritis
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Disease of the Month – Psoriatic arthritis

Shots: Psoriatic arthritis is a chronic inflammatory condition characterized by joint pain, stiffness and swelling  In this reprise of our Disease of the Month report, we present an enlightening description of Psoriatic arthritis with a thorough study of epidemiology, market size, disease management, potential medicines, patient advocacy groups, and the key players involved     For a…
October 16, 2024

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News

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara) 

Shots:  Bio-Thera has entered into an exclusive commercialization and licensing agreement with Gedeon Richter for BAT2206, a biosimilar version of Stelara (ustekinumab)  Bio-Thera will handle development, manufacturing & supply of BAT2206 while Richter will have exclusive commercialization rights across the EU, UK, Switzerland & selected regions. Bio-Thera has already submitted regulatory filing with the EMA…
October 9, 2024

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