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Fresenius Kabi
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Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots:The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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News

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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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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Top Performing Drug – Cosentyx (November Edition)
INSIGHTS+

Top Performing Drug – Cosentyx (November Edition)

Shots:  In continuation of our previous series on the Top-Performing Drug of the month, based on 2021 revenue, this month we have selected Cosentyx and prepared a curated analysis report for our readers Cosentyx is indicated for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis. It is a human IgG1κ mAb which targets interleukin (IL)-17A   PharmaShots presents a…
November 22, 2023

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Viewpoints_Natalie Shiff
VIEWPOINTS

Natalie Shiff, Associate Medical Director, Janssen Rheumatology Shares Insights from the FDA Approval of Stelara to Treat Pediatric Patients with Active Psoriatic Arthritis

Shots:Natalie spoke about the study design and key findings from the P-III study evaluating Stelara for the treatment of pediatric patients with active psoriatic arthritisShe also spoke about the patient support program that is executed by Janssen to support patients to get Stelara The interview gives an understanding of how Janssen is advancing…
October 31, 2022

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