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Viewpoints_Uwe Gudat

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots: At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701P The study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701P Biocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking…

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Biocon Biologics

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara) 

Shots:  Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025  The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…

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Key Biosimilars Events of December 2024

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…

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Key Biosimilars Events of December 2024

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…

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Viewpoints_Uwe Gudat

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…

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Biocon Biologics

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,…

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Insights+ Key Biosimilars Events of February 2024

Insights+ Key Biosimilars Events of February 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   During February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics…

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Biocon Biologics Enters into a Collaboration Agreement with Sandoz for the Commercialization of Ogivri (biosimilar, trastuzumab) and Abevmy (biosimilar, bevacizumab) to Treat Cancer 

Shots:   Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications   Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…

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