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Biocon Biologics
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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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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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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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Key Biosimilars Events of September 2024
INSIGHTS+

Key Biosimilars Events of September 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 Samsung Bioepis and…
October 3, 2024

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News

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

  Shots: Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 2024

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Viewpoints_Sofie Berg
VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in an Illuminating Dialogue Exchange with PharmaShots

Shots: Recently, the European Commission approved AbbVie’s Skyrizi for the treatment of adults with moderate to severe active Ulcerative Colitis The approval was based on positive data from the P-III INSPIRE induction trial and COMMAND maintenance study  Today, at PharmaShots we have Sofie Berg, the therapeutic area head of international immunology, International Medical Affairs, at…
September 23, 2024

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Abbvie
News

AbbVie Reports the CHMP’s Positive Opinion of Skyrizi (Risankizumab) to Treat Ulcerative Colitis 

     Shots: The CHMP grants a positive opinion to Skyrizi for treating moderate to severely active UC in adults with inadequate or lost response and were intolerant to conventional or biologic therapy. Final decision is anticipated in Q3’24 The positive opinion was based on the P-III (INSPIRE) study, assessing Skyrizi (induction treatment: 1200mg, IV, 0,4…
May 31, 2024

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Pfizer New
News

Pfizer’s Velsipity (etrasimod) Receives the European Commission’s Approval for the Treatment of Severely Active Ulcerative Colitis 

Shots:  The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma  Patients in the trial have previously received 1-3 prior lines of therapy,…
February 19, 2024

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