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Formycon and Fresenius Kabi
NEWS

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara) 

Shots:    The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24  The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis)…
July 26, 2024

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NEWS

STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

Shots:    The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions   Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…
July 22, 2024

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Samsung Bioepis
NEWS

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,…
February 22, 2024

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Insights+ Key Biosimilars Events of October 2023
INSIGHTS+

Insights+ Key Biosimilars Events of October 2023

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  During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…
November 1, 2023

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Insights+ Key Biosimilars Events of September 2023
INSIGHTS+

Insights+ Key Biosimilars Events of September 2023

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 During the month of September, Sandoz entered into a development and commercialization agreement…
October 4, 2023

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Viewpoints_Wehkamp Shares
VIEWPOINTS

PharmaShots Interview: Janssen’s Jan Wehkamp Shares Insight on the Data of Stelara (ustekinumab) for IBD and other Approved Indications and Presented 13 Abstracts at UEGW

In an interview with PharmaShots, Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader for the Immunology Therapeutic Area at Janssen Research & Development shared his views on the data from 13 P-II & III studies of Stelara (ustekinumab) for the treatment of IBD and other approved indications Shots: The company has reported the data from 13 P-II & III studies, including 6 studies…
November 24, 2021

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Viewpoints_Jonathan Rigby
VIEWPOINTS

PharmaShots Interview: Janssen’s Andrew Greenspan Shares Insight About the New AGA Guidelines Recommending Stelara (Ustekinumab) as a First-Line Treatment Option in Crohn’s Disease

In an interview with PharmaShots, Andrew Greenspan, VP, Immunology Affairs at Janssen shared his views on the new AGA guidelines on the medical management of moderate-to-severe Crohn's disease and also highlighted about Janssen's efforts in improving the QoL of patients with CD The AGA guidelines assessed the overall benefit of each drug and also compared…
August 17, 2021

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