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Celltrion
News

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots:FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringesDesignation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
May 22, 2025

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Fresenius Kabi
News

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada 

Shots: Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…
May 21, 2025

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

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Weekly Snapshot

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:   Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025 Read More: Recursion Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…
May 9, 2025

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Teva and Alvotech
News

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots:The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…
May 6, 2025

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CuraTeQ
News

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states The opinion…
April 26, 2025

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Gedeon Richter
News

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots: The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab) Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation  Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 2025

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Biocon Biologics
News

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots:Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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