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Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots:  The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease  The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…

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Samsung Bioepis

Samsung Bioepis Highlights 2 Abstracts for SB17 (biosimilar, ustekinumab) for the Treatment of Moderate-to-Severe Psoriasis at ECCO 2024  

Shots:    The first study highlights the results from the analytical assessment of the safety & efficacy of SB17 vs Stelara (ustekinumab) which demonstrated SB17 to be biologically similar to Stelara in terms of its physicochemical, structural & biological attributes   Additionally, the data supports the similarity of SB17 with reference Stelara in terms of the biosimilarity, PK,…

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Top Performing Drug – Cosentyx (November Edition)

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…

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