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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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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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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at EADV Congress 2024: Uwe Gudat in a Stimulating Dialogue Exchange with PharmaShots

Shots:  At the European Academy of Dermatology and Venereology (EADV) 2024 Congress, Biocon Biologics presented results from two pivotal P-III clinical studies. These studies supported the interchangeability between Humira and adalimumab-fkjp, as well as the biosimilarity between Bmab 1200 and Stelara for the treatment of patients with moderate-to-severe plaque psoriasis  In an engaging conversation with…
January 6, 2025

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NEWS

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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Biocon Biologics
NEWS

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara) 

Shots:  The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)  Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen  Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…
December 1, 2024

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Teva and Alvotech
NEWS

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots:  Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25  The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL…
October 22, 2024

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NEWS

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara) 

Shots:  Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab)  Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide…
October 21, 2024

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