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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, 20240Comments

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News

Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology 

  Shots: Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization The agreement…
October 3, 20240Comments

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Viewpoints_Robert Fogel_Dave Singh
VIEWPOINTS

AstraZeneca at ATS’24: Robert Fogel & Dave Singh in a Stimulating Conversation with PharmaShots

Shots: Cardiopulmonary events associated with COPD are responsible for an increasing mortality rate in COPD patients. ETHOS trial, a posthoc analysis navigates BGF’s impact on a wide range of cardiopulmonary outcomes beyond COPD exacerbations The post-hoc analysis reveals that AstraZeneca’s Breztri led to a 20% reduction in the risk of severe cardiopulmonary events. AstraZeneca is currently…
September 30, 20240Comments

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Exclusive_Chris Heery_2024
EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots: Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM) Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma In late 2022,…
September 30, 20240Comments

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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, 20240Comments

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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, 20240Comments

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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, 20240Comments

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GE HealthCare
News

GE HealthCare Reports the US FDA’s Approval of Flyrcado (Flurpiridaz F 18) PET Radiotracer for Improved CAD Diagnosis 

Shots:    The US FDA has approved Flyrcado injection as a PET MPI agent to diagnose CAD, with its launch planned in early 2025  The effectiveness of Flyrcado  was assessed under the P-III (AURORA) study in comparison with both invasive coronary angiography as a standard and SPECT MPI to identify CAD   In addition, GE HealthCare secured…
September 27, 20240Comments

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