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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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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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Formycon and Fresenius Kabi
News

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara) 

Shots:  The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025  Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…
September 30, 2024

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Formycon and Fresenius Kabi
News

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases 

Shots:  The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway  Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…
September 27, 2024

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Formycon and Fresenius Kabi
News

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases   

Shots:  The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway  Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…
September 27, 2024

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xbrane
News

Xbrane Biopharma Reclaims Rights of BIIB801 (Biosimilar, Cimzia) from Biogen 

Shots:  Xbrane Biopharma will reclaim full rights of BIIB801 from Biogen after the termination of their commercialization and license agreement. BIIB801 is a biosimilar version of Cimzia (certolizumab pegol), under non-clinical development  The agreement was signed b/w Xbrane & Biogen in Feb 2022, under which Xbrane received a non-refundable $8M upfront. It has been terminated…
August 1, 2024

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Celltrion
News

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the Health Canada’s Approval to Treat Various Chronic Inflammatory Conditions 

Shots:  Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis  Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…
August 1, 2024

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News

STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases

Shots :  Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway  The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…
January 10, 2024

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