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Fresenius Kabi
News

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 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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ALPCO
News

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Shots: ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…
May 9, 2025

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Sanofi
News

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Shots: Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits Developed using Earendil…
April 17, 2025

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Viewpoints_Anabela Cardoso_Mark Genovese
VIEWPOINTS

Lilly at ACG 2024: Anabela Cardoso and Mark Genovese in Conversation with PharmaShots

Shots:  Lilly presented results from two long-term studies evaluating sustained efficacy in patients treated with mirikizumab for both moderately to severely active Ulcerative Colitis and Crohn’s Disease at ACG 2024  At three years, more than 80 percent of patients with moderately to severely active ulcerative colitis who were on remission sustained long-term remission and relief  …
March 24, 2025

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Eli lilly
News

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

Shots: Approval was based on a P-III (VIVID-1) trial assessing Omvoh vs PBO in mod. to sev. CD patients, unresponsive/intolerable to corticosteroids, BRMs &/or biologics, post its approval for UC in Dec 2023. Regulatory submissions are filed globally, incl. Japan & the EU, with other submissions underway Study showed 53% vs 36% clinical remission &…
January 16, 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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Viewpoints_Mark Genovese 
VIEWPOINTS

Lilly at UEGW 2024: Mark Genovese in an Illuminating Dialogue Exchange with PharmaShots shares insights into VIVID-1 study

Shots:  Recently, at UEGW 2024, Lilly presented histologic and combined histologic-endoscopic outcomes from the VIVID-1 Phase III study, which evaluated the safety and efficacy of mirikizumab in adults with moderately to severely active Crohn’s disease  A key finding reported during UEG Week highlighted the interactions between mirikizumab and ustekinumab, particularly regarding histologic response and remission,…
December 18, 2024

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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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